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Showing 221–240 of 1310 results

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Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Class IIModerate

FDAJun 16, 2025Nationwide• B BRAUN MEDICAL INC

Bupivacaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride 50mg Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCl Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCL with Epinephrine Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Testo-200 Testosterone Injection (Advanced Pharma) – Unapproved Product (2025)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAMay 30, 2025NJ, NY• Advanced Pharmaceutical Technology, Inc.

Icosapent Ethyl Capsules (Zydus) – Burnt Capsules (2025)

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Class IIModerate

FDAMay 30, 2025IL, MS, PA• Zydus Pharmaceuticals (USA) Inc

Gentamicin Pediatric Injection (Eugia) – Stability Failure (2025)

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Class IIModerate

FDAMay 29, 2025Nationwide• Eugia US LLC

Dobutamine Injection (Pfizer) – Discolored Solution (2025)

Discoloration; discolored solution from cracked vials

Class IIModerate

FDAMay 28, 2025Nationwide• Pfizer Inc.

Lacosamide Oral Solution (Apotex) – Leaking Container (2025)

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Ketorolac Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Azelastine HCl Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Brimonidine/Timolol Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Fluoxetine Tablets (Torrent Pharma) - CGMP Nitrosamine Deviation (2025)

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Class IIModerate

FDAMay 27, 2025Nationwide• Torrent Pharma Inc.

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

Lack of Assurance of Sterility

Class IIModerate

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

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

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

Presence of foreign tablets/capsules.

Class IIModerate

FDAMay 23, 2025Nationwide• Teva Pharmaceuticals USA, Inc

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