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Sodium Chloride Injection (Fresenius) - Sterility Concern (2025)

Lack of Assurance of Sterility

FDAMay 27, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Class IIModerate

FDAMay 23, 2025Nationwide• Ascend Laboratories, LLC

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Sodium Chloride Injection (Fresenius) - Sterility Concern (2025)

Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)

Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)

Metoclopramide Tablets (Teva) - Foreign Tablet Contamination (2025)

Acetaminophen Tablets (Aurobindo) - Tablet Discoloration (2025)

Tirzepatide/Cyanocobalamin (Thrive) - Sterility Concern (2025)

Methylcobalamin Injectable (Thrive) - Sterility Concern (2025)

CJC-1295 Injectable (Thrive) - Sterility Concern (2025)

LX Bioboost Plus (Thrive) - Sterility Concern (2025)

LL Bioboost Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Semaglutide/Cyanocobalamin Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Theophylline Extended-Release Tablets (Glenmark) – Dissolution Test Failure (2025)

Indomethacin Extended-Release Capsules (Amerisource) – Manufacturing Deviation (2025)

Airsupra Inhalation Aerosol (AstraZeneca) – Delivery System Defect (2025)

Esomeprazole Magnesium Suspension 20mg (Zydus) – Impurity Specification (2025)

Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Celecoxib Capsules (AvKARE) – Foreign Tablet Contamination (2025)

Celecoxib Capsules (Alembic) – Foreign Tablet Contamination (2025)

Chlorthalidone Tablets (AvKARE) – Dissolution Specification Failure (2025)