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Leader Acetaminophen (Contract Pharmacal) – Foreign Tablet Mix (2020)

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

Class IIModerate

FDAFeb 3, 2020Nationwide• Contract Pharmacal Corporation

Fentanyl Citrate Injection (Pfizer) – Loose Overseal Crimp (2020)

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Class IIModerate

FDAFeb 3, 2020Nationwide

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Leader Acetaminophen (Contract Pharmacal) – Foreign Tablet Mix (2020)

Fentanyl Citrate Injection (Pfizer) – Loose Overseal Crimp (2020)

Ethacrynate Sodium Injection (Zydus) – cGMP Deviation (2020)

Clonidine Tablets (Unichem) – Benzophenone Migration (2020)

Nopalina Flax Seed Fiber Capsules (Salud Natural) – Contamination Risk (2020)

Nopalina Flax Seed Fiber (Salud Natural) – Contamination Risk (2020)

Atorvastatin Tablets (Graviti) – Tablet Mix-up (2020)

Tramadol Tablets (Teva) – Incorrect Package Insert (2020)

Glycopyrrolate Tablets (NCS Healthcare) – Unknown Impurity (2020)

Methylphenidate Extended-Release (Teva) – Missing Desiccant 27mg (2020)

Desmopressin Tablets (Teva) – Missing Desiccant 0.1mg (2020)

Methylphenidate Extended-Release (Teva) – Missing Desiccant 18mg (2020)

Desmopressin Tablets (Teva) – Missing Desiccant 0.2mg (2020)

Solifenacin Succinate Tablets (Breckenridge) – Manufacturing Deviation (2020)

Pioglitazone Metformin Tablets (Macleods) – Subpotent Drug (2020)

Solifenacin Succinate Tablets (Breckenridge) – Manufacturing Deviation (2020)

Olmesartan Tablets (Ascend) – API Source Deviation (2020)

Minocycline Hydrochloride Tablets (Ascend) – Failed Dissolution (2020)

Dietary Supplements (ABH Nature's) – Manufacturing Violation (2020)

Montelukast Sodium Tablets (Macleods) – Failed Dissolution (2020)