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Showing 1–20 of 77 results

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Noxafil Powdermix (Merck) – Metal Particulate Risk (2025)

Presence of particulate matter: potential presence of metal particulates in the product.

Class IIModerate

FDADec 12, 2025Nationwide• Merck Sharp & Dohme LLC

Merck Emend (Merck) – Metal Particulate Risk (2025)

Presence of particulate matter: potential presence of metal particulates in the product.

Class IIModerate

FDADec 12, 2025Nationwide• Merck Sharp & Dohme LLC

Ciclopirox Shampoo (Sun Pharma) – Impurity Specification Failure (2025)

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Class IIModerate

FDADec 9, 2025Nationwide• SUN PHARMA /TARO

Baclofen Tablets (Golden State) – Foreign Tablet Presence (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDANov 26, 2025Nationwide• Golden State Medical Supply Inc.

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Class IIModerate

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Class IIModerate

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Pain Away Herbal Supplement (A New Life Herbs) – misbranded (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IILow

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Sinus Cap Herbal Supplement (A New Life Herbs) – misbranded (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IIModerate

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Organic Ginger Root Supplement (A New Life Herbs) – misbranded (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IILow

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Ear Drops Herbal Supplement (A New Life Herbs) – misbranded product (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IILow

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Ondansetron ODT Tablets (Preferred) – Defective Packaging (2025)

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Class IIModerate

FDANov 17, 2025IN• Preferred Pharmaceuticals, Inc.