Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 61 of 251
Teva Pharmaceuticals USA
Class II Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (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: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these s...
D-0282-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc.,...
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-0281-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA ...
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-0285-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
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-0276-2021 March 3, 2021 Parsippany, NJ
CareFusion 213, LLC
Class I Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 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-0268-2021 March 3, 2021 El Paso, TX
Teva Pharmaceuticals USA
Class II Terminated
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA...
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-0279-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 1...
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-0272-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.
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-0280-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc....
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-0277-2021 March 3, 2021 Parsippany, NJ
The General Hospital Corporation
Class II Terminated
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50
Reason: Lack of Assurance of Sterility
D-0288-2021 March 3, 2021 Boston, MA
Teva Pharmaceuticals USA
Class II Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.
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-0283-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA ...
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-0271-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., Nor...
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-0275-2021 March 3, 2021 Parsippany, NJ
Teva Pharmaceuticals USA
Class II Terminated
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
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-0273-2021 March 3, 2021 Parsippany, NJ
Edge Pharma, LLC
Class II Terminated
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR I...
Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
D-0238-2021 January 27, 2021 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Cus...
Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
D-0226-2021 January 20, 2021 Colchester, VT
SCA Pharmaceuticals
Class II Terminated
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0192-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0203-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0198-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0200-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0214-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0215-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0191-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0202-2021 January 13, 2021 Windsor, CT
SCA Pharmaceuticals
Class II Terminated
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
D-0212-2021 January 13, 2021 Windsor, CT