MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5...
Reason: Non-Sterility
D-0710-2021August 18, 2021Longview, TX
Med Shop Total Care Inc.
Class ITerminated
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 E...
Reason: Non-Sterility
D-0711-2021August 18, 2021Longview, TX
Med Shop Total Care Inc.
Class ITerminated
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG...
Reason: Non-Sterility
D-0708-2021August 18, 2021Longview, TX
Med Shop Total Care Inc.
Class ITerminated
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Reason: Non-Sterility
D-0712-2021August 18, 2021Longview, TX
Med Shop Total Care Inc.
Class ITerminated
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Reason: Non-Sterility
D-0713-2021August 18, 2021Longview, TX
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Class IITerminated
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Reason: Lack of sterility assurance
D-0702-2021August 11, 2021Temple Terrace, FL
Innoveix Pharmaceuticals Inc
Class IICompleted
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason: Lack of Assurance of Sterility
D-0693-2021July 28, 2021Addison, TX
Innoveix Pharmaceuticals Inc
Class IICompleted
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason: Lack of Assurance of Sterility
D-0692-2021July 28, 2021Addison, TX
Teva Pharmaceuticals USA
Class IITerminated
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
Reason: Lack of Assurance of Sterility
D-0378-2021May 26, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER...
Reason: Lack of Assurance of Sterility
D-0374-2021May 26, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
Reason: Lack of Assurance of Sterility
D-0377-2021May 26, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Reason: Lack of Assurance of Sterility
D-0376-2021May 26, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Reason: Lack of Assurance of Sterility
D-0375-2021May 26, 2021Parsippany, NJ
CareFusion 213, LLC
Class IITerminated
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is ...
Reason: Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus pen...
D-0347-2021May 5, 2021El Paso, TX
CareFusion 213, LLC
Class ITerminated
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is ...
Reason: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a b...
D-0343-2021May 5, 2021El Paso, TX
CareFusion 213, LLC
Class ITerminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if pa...
Reason: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a b...
D-0344-2021May 5, 2021El Paso, TX
CareFusion 213, LLC
Class IITerminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if pa...
Reason: Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus pen...
D-0348-2021May 5, 2021El Paso, TX
Edge Pharma, LLC
Class IITerminated
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr...
Reason: Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
D-0335-2021April 28, 2021Colchester, VT
Sagent Pharmaceuticals Inc
Class IITerminated
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg...
Reason: Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
D-0305-2021March 24, 2021Schaumburg, IL
CareFusion 213, LLC
Class ITerminated
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 799...
Reason: Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, ther...
D-0265-2021March 3, 2021El Paso, TX
Teva Pharmaceuticals USA
Class IITerminated
Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.
Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these s...
D-0274-2021March 3, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.
Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these s...
D-0278-2021March 3, 2021Parsippany, NJ
Teva Pharmaceuticals USA
Class IITerminated
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.
Reason: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these s...