Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

Class IIModerate

FDAFeb 4, 2025Nationwide• AvKARE

Trader Joe's Low Sodium Albacore Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Genova Solid White Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Salted Albacore Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Albacore Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Genova Yellowfin Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Albacore Tuna in Olive Oil – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Van Camp's Solid Light Yellowfin Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Genova Yellowfin Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Beverage Base Lemonade (OCBW) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDAJan 31, 2025AR, CA, CO +5 more• OCBW INC

Ciprofloxacin Ophth Solution (Direct Rx) – Bottle Defect (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDAJan 31, 2025AL, CA, FL +3 more• Direct Rx

Fentanyl Citrate (Fagron) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 31, 2025IN, PA• Fagron Compounding Services

Beverage Base Sweet&Sour (OCBW) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDAJan 31, 2025AR, CA, CO +5 more• OCBW INC

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 30, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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