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Showing 121–140 of 1571 results

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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 20mg (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

Atorvastatin Tablets 10mg (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

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

Failed Dissolution Specifications

Class IIModerate

FDASep 19, 2025Nationwide• Ascend Laboratories, LLC

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

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

CGMP Deviations

Class IIModerate

FDASep 17, 2025MO• Park Avenue Compounding

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

FDASep 16, 2025Nationwide• IntegraDose Compounding Services LLC

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

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

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.

Cetirizine Hydrochloride Tablets 500ct (JB Chemicals) – incorrect tablet imprint (2025)

Tablet/Capsules Imprinted with Wrong ID

FDASep 12, 2025Nationwide• JB Chemicals and Pharmaceuticals Ltd

Cetirizine Hydrochloride Tablets (JB Chemicals) – incorrect tablet imprint (2025)

Tablet/Capsules Imprinted with Wrong ID

FDASep 12, 2025Nationwide• JB Chemicals and Pharmaceuticals Ltd

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.

Everolimus Tablets (Endo USA) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDASep 5, 2025Nationwide• Endo USA, Inc.

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