Class I - Dangerous
Failed Impurities/Degradation Specifications:
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications:
Class I - Dangerous
Failed Impurities/Degradation Specifications:
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Fagron Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Impurity/Degradation Specifications
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Amerisource Health Services
Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
Amerisource Health Services
Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I - Dangerous
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
B BRAUN MEDICAL
Class I - Dangerous
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Amerisource Health Services
Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I - Dangerous
Superpotent drug
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class I - Dangerous
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Impurity/Degradation Specifications
cGMP deviations: Temperature excursion during transportation.
Class I - Dangerous
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
Zydus Pharmaceuticals (USA)
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
Zydus Pharmaceuticals (USA)
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
Zydus Pharmaceuticals (USA)
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit