💊

Prescription Drugs

💊 Drugs • 11,927 recalls

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Rising Pharma Holding

Class I - Dangerous

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

Dec 30, 2024 Prescription Drugs Nationwide View Details →

Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).

Endo USA

Class I - Dangerous

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

Granules Pharmaceuticals

Class I - Dangerous

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Dec 30, 2024 Prescription Drugs View Details →

Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).

Endo USA

Class I - Dangerous

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Rising Pharma Holding

Class I - Dangerous

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

Dec 30, 2024 Prescription Drugs Nationwide View Details →

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

VIONA PHARMACEUTICALS

Class I - Dangerous

Crystallization

Dec 10, 2024 Prescription Drugs Nationwide View Details →

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

AvKARE

Class I - Dangerous

Failed Dissolution Specifications

Dec 4, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

Lupin Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Dec 20, 2024 Prescription Drugs View Details →

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

Hikma Injectables USA

Class I - Dangerous

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Dec 19, 2024 Prescription Drugs Nationwide View Details →

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

GNMart

Class I - Dangerous

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Hikma Injectables USA

Class I - Dangerous

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Dec 19, 2024 Prescription Drugs Nationwide View Details →

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

SOMERSET THERAPEUTICS

Class I - Dangerous

Failed Impurities/Degradation Specifications

Dec 16, 2024 Prescription Drugs Nationwide View Details →

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

VIONA PHARMACEUTICALS

Class I - Dangerous

Crystallization

Dec 10, 2024 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) 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 →

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

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 →

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40

Curium US

Class I - Dangerous

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

Nov 26, 2024 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

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 →

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

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 →

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

RemedyRepack

Class I - Dangerous

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

Dec 2, 2024 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

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 →

← Back to All Drugs Recalls