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Showing 101–120 of 1310 results

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Succinylcholine Chloride Injection (Dr. Reddy's) – Stability Issue (2025)

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Class IIModerate

FDASep 26, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Entecavir Tablets 0.5mg (Zydus) – Impurity Specifications (2025)

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Class IIModerate

FDASep 24, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Entecavir Tablets 1mg (Zydus) – Impurity Specifications (2025)

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Class IIModerate

FDASep 24, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Fentanyl/Ropivacaine Solution (Park Avenue) – CGMP Deviation (2025)

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Class IIModerate

FDASep 23, 2025IN, MO• Park Avenue Compounding

Atorvastatin Tablets 10mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 80mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 20mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 40mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDASep 17, 2025MO• Park Avenue Compounding

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

CGMP Deviations: Market complaints received for gritty texture (grainy)

Class IIModerate

FDASep 17, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Levothyroxine Tablets (Accord) – Subpotent Medication (2025)

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Class IIModerate

FDASep 16, 2025Nationwide• ACCORD HEALTHCARE, INC.

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Failed Tablet/Capsule Specifications

Class IIModerate

FDASep 15, 2025Nationwide• Graviti Pharmaceuticals Private Limited

Carbamazepine Tablets (Amerisource) – Dissolution Issue (2025)

Failed Dissolution Specifications.

Class IIModerate

FDASep 15, 2025Nationwide• Amerisource Health Services LLC

Baby Bedtime Drops (M.O.M Enterprises) – Yeast Contamination (2025)

Potential yeast contamination.

Class IIModerate

FDASep 12, 2025AL, AZ, AR +30 more• M.O.M Enterprises, LLC.

ChlorproMAZINE Hydrochloride Tablets (Major Pharmaceuticals) – N-Nitroso impurity (2025)

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Class IIModerate

FDASep 12, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Cyclophosphamide Injection (Sandoz) – temperature excursion (2025)

cGMP deviations: Temperature excursion during transportation.

Class IIModerate

FDASep 5, 2025Nationwide• Sandoz Inc

Brimonidine/Timolol Ophthalmic Solution (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

Ketorolac Tromethamine Eye Drops (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

FemiClear Daily Bladder Strength (Organicare) – Microbial Contamination (2025)

Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.

Class IIModerate

FDASep 4, 2025IN, PR• Organicare Nature's Science, LLC

Entecavir Tablets 0.5mg (Zydus) – impurity specification failure (2025)

Failed Impurity/Degradation Specifications

Class IIModerate

FDASep 4, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

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