Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum,  burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Restaurant Recycling Services, LLC decided to initiate this voluntary recall out of an abundance of caution due to information received from the FDA and Michigan Department of Agriculture regarding possible lasalocid contamination.
All tanker loads distributed: July 1, 2014 through September 24, 2014
Nationwide, Alaska, Hawaii, and Puerto Rico.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US)  and 1650, 1650-DE and A00035 (OUS)    Product Usage:  Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Serial numbers ranging BAT000001 to BAT199999.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5553-3.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5554-3.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5555-3.
PEPPERMINT ESSENTIAL OIL repacked into the following:   1) Radha Peppermint Oil, 100% Pure & Natural Peppermint Essential Oil Premium Therapeutic Grade, 4 Fl oz (120 ml), UPC 0 784672901284, Distributed by Radha Beauty 651 Addison St. Berkeley, CA 94710,   2) MAJESTIC PURE COSMECEUTICALS Peppermint essential oil 100% Pure & Natural Therapeutic Grade, 4 FL. OZ (118ML), Distributed by Majestic Pure Cosmeceuticals San Diego, CA 92131,   3) BODY WONDERS 100% PURE Peppermint Therapeutic Grade Essential Oil, 4 fl oz (118 ml), UPC 8 19090016589, Manufactured for and Distributed by: Body Wonders NJ 07030,   4) PURE BODY NATURALS PEPPERMINT OIL 100% PURE AND NATURAL, Premium Quality Therapeutic Grade Undiluted Essential Oil, 4 FL OZ 120 ML, UPC 0 784672 901284, Distributed By: Pure Luxe LLC, Houston, TX 77008-3642,   5) ESSENTIAL OIL LABS PEPPERMINT OIL, 4 FL OZ (120 ml), Essential Oil Labs 8605 Santa Monica Blvd #64787 Los Angeles, CA 90069,   6) Essentially Kates Premium Peppermint Oil, 4 fl oz/120 ml, Imported from India, Bottled in the USA for Essentially Kates Greeley, CO 80634
and contains undeclared Diethyl phthalate
Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA
Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68
All Sterile Compounded Products within Expiry
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01
Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0100-69
Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride  10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72
Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC # 45183-0174-02
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only,  Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx  Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride  50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0504-41
Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only,  Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
Provocholine pre-diluted in 0.9% Sodium Chloride Set II  syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70
Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03
Lidocaine 2%,  5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0946-70
Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02
Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48
Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only,   Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01
HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78
Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68
Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0934-70
Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48
Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 500 mL  lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0993-03
HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0933-75
Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0187-41
Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia  bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04
Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72
Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride,  50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
Propofol1% 10mg/mL injection,  20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03
Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride,  50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68
Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02
Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0955-70
Bupivacaine HCI 0.125% in 0.9% Sodium Chloride,  250 mL  lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0909-02
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03
Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0938-68
Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70
Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67
Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75
Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41
Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72
Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78
Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride  250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC  45183-0702-68
Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride,  50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose,  250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48
Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.
SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.
Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.
PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.
FARSER KAI YEUNG PILL, packaged in a bottle within a box,  Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters.
PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.
LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters.
Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
Shipper case lot #8008580, Retal Carton Lot #4543U8008580
distributed in California, Texas and Washington
Central Markets Organics Mixed Vegetables, frozen, net wt. 16 oz. UPC 4122010249  		  HEB Organics Mixed Vegetables, frozen, net wt. 16 oz. UPC 4122004013  		  Sweetfrost Mixed Vegetables, frozen, net wt. 16 oz. UPC 7307381875    Woodstock Organic Mixed Vegetables, net wt. UPC 10 oz. UPC 4256300160
Organics Mixed Vegetables are recalled due to the potential for these products to be contaminated with Listeria monocytogenes.
Central Markets Organics Mixed Vegetables: Best Used By DEC.05.2017 and Best Used By JAN.11.2018.    HEB Organics Mixed Vegetables: Best Used By MAR.04.2018 and Best Used By MAR.25.2018.    Woodstock Organic Mixed Vegetables: Best Used By JAN.11.2018.    Sweetfrost Mixed Vegetables: 20886
Central Markets Organics Green Peas, frozen, net wt. 16 oz. UPC 4122010240    Central Markets Organics Green Peas, frozen,  net wt. 12 oz. UPC 4122081674
Central Market Organic Peas recalled due to the potential for these products to be contaminated with Listeria monocytogenes.
Best Used By DEC.09.2017  Best Used By JAN.08.2018
Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
Kit labeled with the incorrect expiration date.
Trader Joe's Quinoa Cowboy Veggie Burger, 26 x 12 oz. (340g)/box, Best if used by: May-12-2018, UPC 0053 2761, Dist. & Sold Exclusively By: Trader Joe's, Monrovia CA 91016
Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes.
Lot #F16BC-01A    TJQCB26  Case code: N16CI-02A Retail unit code: N16CI Best by: 1/28/2018  Case code: N16CI-02B Retail unit code: N16CI Best by: 1/28/2018  Case code: N16CI-02D Retail unit code: N16CI Best by: 1/28/2018  Case code: T16AE-01A Retail unit code: T16AE Best by: 2/04/2018  Case code: T16BB-01A Retail unit code: T16BB Best by: 2/11/2018  Case code: T16CF-01A Retail unit code: T16CF Best by: 2/25/2018  Case code: H16AE-01A Retail unit code: H16AE Best by: 3/04/2018  Case code: H16BA-02A Retail unit code: H16BA Best by: 3/10/2018  Case code: H16BH-01A Retail unit code: H16BH Best by: 3/17/2018  Case code: H16BA-02C Retail unit code: H16BA Best by: 3/10/2018  Case code: R16AG-01A Retail unit code: R16AG Best by: 4/06/2018  Case code: R16AG-01B Retail unit code: R16AG Best by: 4/06/2018  Case code: R16CA-06A Retail unit code: R16CA Best by: 4/20/2018
Dr. Praeger's Chipotle Black Bean Burger, 4.25 oz., 10 lbs  (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06621 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-24A    SVB-CBBIN425  Case code: H16AI-07A Retail unit code: H16AI Best by: 3/08/2018  Case code: H16AI-07B Retail unit code: H16AI Best by: 3/08/2018
Dr. Praeger's California Veggie Burgers, 6 x 10 oz. (238g)/box, Best if used by: May-10-2018, UPC (01) 6 0080868 00010 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BA-01B    VBCA06  Case code: T16BI-02A Retail unit code: T16BI Best by: 2/18/2018  Case code: R16BD-01A Retail unit code: R16BD Best by: 4/13/2018  Case code: H16AI-04A Retail unit code: H16AI Best by: 3/08/2018  Case code: H16CD-02A Retail unit code: H16CD Best by: 3/23/2018  Case code: T16AJ-02C Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CD-02A Retail unit code: T16CD Best by: 2/23/2018
Dr. Praeger's Black Bean Burger (CN Labeled) (Vegetarian), 3.3 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06616, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-23A    SVB-SWIN33-CN  Case code:H16AI-06A Retail unit code: H16AI Best by: 3/08/2018
Dr. Praeger's Black Bean Veggie Burger, 12 x 10 oz. (283 g)/box, Best if used by: May-12-2018, UPC 0 80868 06019 4, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-21A    SVB-BB12  Case code: N16CH-04A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-04Z Retail unit code: N16CH Best by: 1/27/2018
Dr. Praeger's California Veggie Burgers, 12 x 11 oz. (312g)/box, Best if used by: May-16-2018, UPC 0 0080868 000010 7, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BG-03C    VB12  Case code: N16CH-01A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-01Z Retail unit code: N16CH Best by: 1/27/2018  Case code: T16AD-01A Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AD-01Z Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AJ-02B Retail unit code: T16AJ Best by: 2/09/2018
Dr. Praeger's Sensible Foods Organic Harvest Veggie Burgers, 10 x 1.36kg, (48 oz. (3 lbs)),  Best if used by: May -16-2017, Distributed by: Costco Wholesale UK Ltd,  UPC 0 8086830110 6
Lot #F16BG-02B    LCOVB-R10-UK  Case code: W14BB-01A Retail unit code: W14BB Best by: 12/11/2015  Case code: R15CA-02A Retail unit code: R15CA Best by: 4/20/2016  Case code: F15CG-04A Retail unit code: F15CG Best by: 5/26/2016
Aldi California/Black Bean Veggie Burgers, Net 15.0 lbs, 24 x 10 oz (284g)/box, Sale By: May -09-2018
Item #47198    AL-47198-R24    Case code: ALDI-04A Retail unit code: H16CE Best by: 3/24/2018  Case code: ALDI-04B Retail unit code: H16CE Best by: 3/24/2018
Dr. Praeger's Black Bean Burger (Vegetarian), 3.3 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06617, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-22A    SVB-SWIN33  Case code: N16CI-03A Retail unit code: N16CI Best by: 1/28/2018  Case code: F16AE-03C Retail unit code: F16AE Best by: 5/04/2018
Dr. Praeger's Bombay Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: May-12-2018, UPC (01) 6 0080868 000050 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-27A    VBBY06  Case code: N16CH-02B Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-02A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH Retail unit code: N16CH Best by: 1/27/2018
Dr. Praeger's California Veggie Burgers, 26 x 10 oz./box, Best if used by: May-18-2018, UPC 0 80868 00010, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BI-01A    VB26  Case code: N16CH-01B Retail unit code: N16CH Best by: 1/27/2018  Case code: T16AD-01B Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AJ-02A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16BI-02B Retail unit code: T16BI Best by: 2/18/2018  Case code: T16BI-02D Retail unit code: T16BI Best by: 2/18/2018  Case code: T16CD-02B Retail unit code: T16CD Best by: 2/23/2018  Case code: T16CE-03A Retail unit code: T16CE Best by: 2/24/2018  Case code: H16AI-04B Retail unit code: H16AI Best by: 3/08/2018  Case code: H16AJ-01A Retail unit code: H16AJ Best by: 3/09/2018  Case code: H16BG-02A Retail unit code: H16BG Best by: 3/16/2018  Case code: H16BG-02N Retail unit code: H16BG Best by: 3/16/2018  Case code: H16DA-01A Retail unit code: H16DA Best by: 3/30/2018  Case code: R16AH-01A Retail unit code: R16AH Best by: 4/07/2018  Case code: R16BD-01B Retail unit code: R16BD Best by: 4/13/2018
Dr. Praeger's California Veggie Burger Sliders (Vegan), 1.5 oz., 10 lbs. (4.54 kg), Best if used by: May-17-2018, UPC (01) 0 0080868 01015, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BH-02A    VBIN-SL  Case code: T16AJ-04C Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03D Retail unit code: T16CE Best by: 2/24/2018  Case code: T16CE-03G Retail unit code: T16CE Best by: 2/24/2018  Case code: R16BJ-03A Retail unit code: R16BJ Best by: 4/19/2018  Case code: R16BJ-03B Retail unit code: R16BJ Best by: 4/19/2018
Dr. Praeger's California Veggie Balls (Vegan), 1 oz., 10 lbs. (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01310, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-25B    VBBIN  Case code: H16CB-02B Retail unit code: H16CB Best by: 3/21/2018  Case code: H16CB-02D Retail unit code: H16CB Best by: 3/21/2018  Case code: H16CB-02C Retail unit code: H16CB Best by: 3/21/2018
Dr. Praeger's Purely Sensible Foods Jumbo California Veggie Burger (Vegan), 5.5 oz., 10 lbs (4.54.kg), Best if used by: May 17, 2018, UPC (01) 00080868 01011, Dr. Praegers Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BH-02B    JVBIN  Case code: T16CE-03E Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03A Retail unit code: H16BF Best by: 3/15/2018  Case code: R16AF-03D Retail unit code: R16AF Best by: 4/05/2018  Case code: R16AG-02A Retail unit code: R16AG Best by: 4/06/2018  Case code: R16AG-02B Retail unit code: R16AG Best by: 4/06/2018
Dr. Praeger's Black Bean Burger (Vegetarian), 4.25 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06619, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-22B    SVB-SWIN4  Case code:H16AI-05A Retail unit code: H16AI Best by: 3/08/2018
Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs  (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 01010 6, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BG-03B    VBIN4  Case code: T16AJ-04A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03C Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03B Retail unit code: H16BF Best by: 3/15/2018  Case code: H16BF-03D Retail unit code: H16BF Best by: 3/15/2018  Case code: H16CE-01B Retail unit code: H16CE Best by: 3/24/2018  Case code: R16AF-03B Retail unit code: R16AF Best by: 4/05/2018  Case code: R16AF-03E Retail unit code: R16AF Best by: 4/05/2018  Case code: R16CB-01B Retail unit code: R16CB Best by: 4/21/2018
Ungar's Veggie Balls (Vegan), 1 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC 0 0080868 81310 3, Ungar's Food Products, Elmwood Park, NJ 07407
Lot #F16BC-25A    UVBBIN  Case code: H16CB-02A Retail unit code: H16CB Best by: 3/21/2018
Dr. Praeger's Tex Mex Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: Jan -4-2018, UPC (01) 6 0080868 00048 , Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #N16AE-11R    VBTM06  Case code: H16AI-03A Retail unit code: H16AI  Best by: 3/08/2018
Dr. Praeger's Purely Sensible Foods Organic Harvest Veggie Burgers, 10 x 48 oz (1.36kg), Best if used by: May 16, 2017, UPC 0 8086830110 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BG-02A    LCOVB-R10  Case code: L14CG-03A Retail unit code: L14CG Best by: 11/26/2015  Case code: L14CG-03B Retail unit code: L14CG Best by: 11/26/2015  Case code: W14BB-01B Retail unit code: W14BB Best by: 12/11/2015  Case code: N15CC-03A Retail unit code: N15CC Best by: 1/22/2016  Case code: F15CG-04B Retail unit code: F15CG Best by: 5/26/2016  Case code: F15CG-04C Retail unit code: F15CG Best by: 5/26/2016  Case code: V15AG-02A Retail unit code: V15AG Best by: 7/06/2016  Case code: G15BA-02A Retail unit code: G15BA Best by: 8/10/2016  Case code: E15CG-03A Retail unit code: E15CG Best by: 10/26/2016  Case code: L15AC-03A Retail unit code: L15AC Best by: 11/02/2016  Case code: L15CD-01A Retail unit code: L15CD Best by: 11/23/2016  Case code: L15CD-01B Retail unit code: L15CD Best by: 11/23/2016  Case code: H16CI-02A Retail unit code: H16CI Best by: 3/28/2017
Dr. Praeger's Black Bean Slider, 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06615, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-26A    VBBINSL165I  Case code: N16CB-05A Retail unit code: N16CB Best by: 1/21/2018  Case code: H16AI-08A Retail unit code: H16AI Best by: 3/08/2018
Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs  (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 97010 3, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BG-03A    VBIN4-C  Case code: T16AJ-04A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03B Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03C Retail unit code: H16BF Best by: 3/15/2018  Case code: H16CD-02B Retail unit code: H16CD Best by: 3/23/2018  Case code: H16CE-01A Retail unit code: H16CE Best by: 3/24/2018  Case code: R16AF-03A Retail unit code: R16AF Best by: 4/05/2018  Case code: R16CB-01A Retail unit code: R16CB Best by: 4/21/2018
Aldi Kale Burger, Net 18.75 lbs, 30 x 10 oz (284 grams), Sell By: May -17-2018
Item #50206    AL-50206-R30  Case code: H16AH-02A Retail unit code: H16AH Best by: 3/07/2018  Case code: H16AH-02B Retail unit code: H16AH Best by: 3/07/2018  Case code: H16CC-01A Retail unit code: H16CC Best by: 3/22/2018
Dr. Praeger's GF California Veggie Burger, 4 oz., 10 lbs  (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01060, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Lot #F16BC-20A    GLVBIN4  Case code: H16CJ-01A Retail unit code: H16CJ Best by: 3/29/2018
Product was distributed to 40 different customers in 87 different U.S. locations. See attached spreadshett for a customer list.
Quaker Quinoa Granola Bars, yogurt, fruit and nut flavor  packaged in a multi colored box with brown lettering. 5, 1.23 oz bars per box.
970 cases, 12 units per case, 5 bars per unit
Sunflower kernels used in Quinoa bars are contaminated with Listeria Monocytogenes.
best before date October 10, 2016 and October 11, 2016
Quaker Quinoa Granola Bars, Chocolate Nut Medley packaged in a multi colored box with brown lettering. 5, 1.23 oz bars per box.
470 cases, 12 units per case, 5 bars per unit.
best before date October 16, 2016 and October 17, 2016
Product was shipped to locations in TX, OH, IL, CT, AL, FL, WI, CO and New Zealand
Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box.
Samples of dehydrated chipotle powder came back positive for gluten, possibly from wheat. Potential presence of wheat was not disclosed on label.
Zesty Nacho Spice Blend (containing dehydrated chipotle powder) from Silva International packaged in a 50 lb. poly-lined cardboard box.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Failed Impurities/Degradation Specification; 9 month stability
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Platelet Pheresis, Leukocytes Reduced, Irradiated
Platelet, labeled with an incorrect volume, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
Labeling does not match the cleared indications for use in the United States and Canada.
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
Worldwide Distribution -- USA, including the states of AL,  AR, CA,  CT,  DC,  FL,  GA,  IL, KS, KY, LA,  MA,  MD,  ME,  MI, MN, MS, NC,  NJ,  NY, OH, PA,  SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815.  Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile.    Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators.     For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80.    Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
All units manufactured between October 2014 and May 2016.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, in which routine resting and/or performed, interpreted or documented incorrectly, was distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam
Preamendments device-Sarns  Dual Cooler-Heater.      The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000  pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures.    Product Usage:  The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160);  Dual Cooler Heater 220V/50Hz (P/N 4332);  Dual Cooler Heater 1 OOV/60Hz (P/N 14114);  Dual Cooler Heater 1 OOV/50Hz (PIN 13460)
Sarns TCM II;     The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an  extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood  temperature.    Product Usage:  The Sarns TCM II is indicated for controlling and monitoring patient temperature.
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
The Sarns Temperature Control and Monitor unit (TCM), TCM II TUV, 115V (P/N 4415),  TCM II TUV, 220V (P/N 4416),  TCM II, with Cardioplegia, 11 OV/60Hz (P/N 164925)  TCM II, without Cardioplegia, 110V/60Hz (P/N 164930)  TCM II, with Cardioplegia, 220V/50Hz (P/N 164935)  TCM II, without Cardioplegia, 220V/50Hz (P/N 164940)
Sarns TCM;     The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice  supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature.    Product Usage:  The Sarns TCM is indicated for controlling and monitoring patient temperature.
The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747
Temperature Management Systems, P/N 809810, Catalog Number 809810
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only,  Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098	    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # SD313.012,  Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg	7/18/2007-8/2/2007    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # SD313.012,  Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg	7/18/2007-8/2/2007
Part # 313.232,  2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # 313.232,  2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Screwdriver Blade, Handle, Drill Bit,  Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short	Lot # 5053859    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part Number: 313.945, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short, Lot # 5053859, mfg. 7/28/2005, No Expiration Date product provided  Non Sterile
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg.  2/12/2002-5/23/2005    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005
Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
Target Detachable Coils:  TARGET HELICAL NANO 3MM X 6CM  MODEL Number:M0035453060      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
45,302 (8,188 in the U.S.) - total, all model numbers
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Target Detachable Coils:  TARGET 360 NANO 1 MM X 2 CM  MODEL Number: M0035421020    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 1 MM X 3 CM  MODEL Number: M0035421030    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 3 CM  MODEL Number:M0035431030        Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 2MM X 3CM  MODEL Number:M0035442030      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 2 CM  MODEL Number:M0035431520      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 2MM X 4CM    MODEL Number:M0035452040            Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 2.5 MM X 4CM  MODEL Number:M0035442540      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 3.5 MM X 6CM  MODEL Number:M0035443560      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 3MM X 8CM  MODEL Number:M0035453080      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 3MM X 4CM  MODEL Number:M0035453040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
MODEL Number:M0035453040;    Lot Number/Expiration Date:  18603553	30-Sep-18
Target Detachable Coils:  TARGET HELICAL NANO 2.5MM X 3CM  MODEL Number:M0035452530      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 2 CM  MODEL Number: M0035421520    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 2 CM  MODEL Number:M0035431020      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 2MM X 3CM  MODEL Number:M0035452030          Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 3MM X 4CM  MODEL Number:M0035443040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 3MM X 4CM  MODEL Number:M0035452560    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 1 CM  MODEL Number:M0035431510    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 2MM X 4CM  MODEL Number:M0035442040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 2MM X 2CM  MODEL Number:M0035452020        Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 2MM X 6CM  MODEL Number:M0035452060            Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 2.5MM X 4CM  MODEL Number:M0035452540      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 4 CM  MODEL Number:M0035431540    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 3 CM  MODEL Number: M0035421530    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 3 CM  MODEL Number:M0035431530      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 3MM X 6CM  MODEL Number:M0035443060      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 1 CM  MODEL Number:M0035431010    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 4 CM  MODEL Number:M0035421540    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Baked in the Sun 4 Pack Smore's Muffin, Wholesale item (food service), not labeled for individual retail sale.    4 pcs/carton
Baked in the Sun is recalling Smores Muffin because it may contain undeclared peanut residual.
WOW 101 TENDER BATTER, NET WT. 25 lbs, ITEM #: WOW101TNBT025
There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.
OUTBACK STEAKHOUSE  CRAWFISH/CHICKEN/CALAMARI BREADER, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA  70123
OUTBACK STEAKHOUSE  OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL  33609
OUTBACK STEAKHOUSE  COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA  70123
Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.
U.S. Nationwide, Japan, and New Zealand.
LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY
DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY
DEXPANTHENOL 250MG/ML W/PRES.  (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials,  b) 50ML Vials, and c) 100ML Vials,  MEDAUS PHARMACY
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY
TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY
NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%)  ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML;  5ML Vials, MEDAUS PHARMACY
M.I.C./B-COMPLEX (PF)  B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY
M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY
PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
HYDROXY B12 5MG/ML W/PRES  (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
ESTRADIOLVAL 3MG/TEST CYP 35MG/  TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
M.I.C. 25/50/50 (PF)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
MANGANESE CHL 0.1MG/ML PF,  10ML Vials, MEDAUS PHARMACY
B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML,   2ML Vials, MEDAUS PHARMACY
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY
B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
HYDROXY B12 1000MCG/ML   W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY
MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY
GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
B-COMPLEX 50 IN NACL 0.9% (PF)  B1-50MG, B2-5-PO4-5MG, B3-50MG,  B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials,  MEDAUS PHARMACY
FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY
TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY
B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY
DMSO 99.9 (PF), In a)  5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%)  B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG;  CYANO B12 100MCG; CHOLINE CHL-50MG;  INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%),  5ML Vials, MEDAUS PHARMACY
B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials  and b) 10ML Vials, MEDAUS PHARMACY
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials,  MEDAUS PHARMACY
FOLIC ACID 10MG/ML W/PRES.  (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY
CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials,  b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG  W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
DMPS 50MG/ML (PF), 5ML Vials,  MEDAUS PHARMACY
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%)  B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY
GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY
M.I.C B-COMPLEX PREMIX W/HYDROXY B12  W/PRES. (BENZALKONIUM 0.01%)  HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,  B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG,  METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY
US distribution in the states of TN and KY.
Femoral Arterial Line  Catheterization Kit with Sharps Safety Features  510K 810675, product code DQX, Device Listing D025180  Material ASK-04018-VUH    Product Usage:  The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Labeling error.  Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)    Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified.  The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA.  There was no government/military/foreign distribution.
Merge OfficePACS software.  The firm name on the label is Merge Healthcare, Heartland, WI.
Potential data loss occurs as a result of product archiving not working properly.
The software was distributed nationwide to medical facilities.  There was no government/military/foreign distribution.
Merge OfficePACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.  OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Potential data loss occurs as a result of the software archiving not working properly.
Worldwide distribution including US nationwide. No Canadian distribution.
Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Stryker Instruments Div. of Stryker Corporation
US Distribution to the states of : CA, IL, SD  Foreign: Canada, Netherlands
Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
North Carolina; Indiana; Illinois; California
Blood products, collected from two donors who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, were distributed.
W040715125068 (double collection); W040714590355 (double collection); W040712432592 (double collection)
Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE;    Radiology: The AlignRT Plus system is indicated for use to position  and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
Varian Medical Systems has received reports that unintended changes were made to planned couch  parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user  sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical  Surface Monitoring System [OSMS].
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE;    Radiology: The AlignRT Plus system is indicated for use to position  and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
166 OSMS in US, 23 OSMO - International,
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].