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Prescription Drugs

💊 Drugs • 11,927 recalls

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Dec 11, 2024 Prescription Drugs Nationwide View Details →

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

PD-Rx Pharmaceuticals

Class I - Dangerous

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Dec 4, 2024 Prescription Drugs View Details →

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Dec 6, 2024 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

Amerisource Health Services

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Dec 6, 2024 Prescription Drugs Nationwide View Details →

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

Provepharm

Class I - Dangerous

Discoloration

Nov 22, 2024 Prescription Drugs Nationwide View Details →

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

Aurobindo Pharma USA

Class I - Dangerous

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Dec 6, 2024 Prescription Drugs Nationwide View Details →

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

Macleods Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications

Nov 25, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20

Mylan Institutional

Class I - Dangerous

Subpotent and Superpotent Drug

Nov 19, 2024 Prescription Drugs Nationwide View Details →

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications

Nov 22, 2024 Prescription Drugs Nationwide View Details →

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

Ascend Laboratories

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Dec 12, 2024 Prescription Drugs Nationwide View Details →

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