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Showing 181–200 of 548 results

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Bimatoprost (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Voriconazole (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Finasteride (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Chlorambucil (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

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

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

HEB Solid White 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

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 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

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

Fentanyl Citrate (Fagron) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 31, 2025IN, PA• Fagron Compounding Services

SinuCleanse Saline Packets (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Neti Pot (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Soft Plum (AAHU BARAH) – Undeclared Sulfites (2025)

Undeclared Allergen

Product contains undeclared sulfites (4.66 mg/serving).

Class IIModerate

FDAJan 9, 2025CO, FL, GA +10 more• Global Commodities Inc

Ultra Repair Cream (First Aid Beauty) – distribution error (2024)

CGMP Deviations; product intended for quarantine was inadvertently distributed

Class IIModerate

FDADec 23, 2024Nationwide• First Aid Beauty Ltd

Systane Eye Drops (Alcon) – non-sterility concern (2024)

Non-Sterility

FDADec 18, 2024Nationwide• Alcon Research LLC

Tutti-Frutti (Three Rivers) - Undeclared Coloring (2024)

Undeclared Allergen

Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.

Class IIModerate

FDADec 12, 2024CT, DE, MD +6 more• Shata Traders Inc.

Made Good Variety Pack (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Strawberry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Mixed Berry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

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