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Showing 281–300 of 1639 results

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Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

Testosterone Pellet (Qualgen) – Incorrect Label Printing (2025)

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

FDAJun 16, 2025Nationwide• Qualgen, LLC

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

Lisdexamfetamine Capsules 60mg (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Class IIModerate

FDAJun 16, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Pitavastatin Tablets 2mg (Orient Pharma) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications.

FDAJun 11, 2025NJ• Orient Pharma Co., Ltd. Yunlin Plant

Famciclovir Tablets 500mg (Macleods) – Foreign Substance Found (2025)

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

FDAJun 11, 2025Nationwide• Macleods Pharmaceuticals Ltd

Pitavastatin Tablets 1mg (Orient Pharma) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications.

FDAJun 11, 2025NJ• Orient Pharma Co., Ltd. Yunlin Plant

Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

FDAJun 2, 2025Nationwide• Amneal Pharmaceuticals, LLC

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

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 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

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

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

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

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.

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

Levothyroxine Sodium Tablets (Macleods) – Foreign Substance (2025)

Presence of a foreign substance: black hair found embedded in tablet.

FDAMay 29, 2025Nationwide• Macleods Pharmaceuticals Ltd

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

Lack of Assurance of Sterility

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.

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