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Imipramine Pamoate Capsules (Lupin) – Dissolution Test Failure (2021)

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

FDAOct 8, 2021Nationwide• Lupin Pharmaceuticals Inc.

Cetirizine Tablets (A-S Medication) – Incorrect Labeling (2021)

Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

Class IIILow

FDAOct 5, 2021FL, IN, MN +1 more• A-S Medication Solutions LLC.

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Imipramine Pamoate Capsules (Lupin) – Dissolution Test Failure (2021)

Cetirizine Tablets (A-S Medication) – Incorrect Labeling (2021)

Omeprazole Capsules (Dr. Reddy's) – Foreign Object Risk (2021)

Ezetimibe Simvastatin 10/40mg (Dr. Reddy's) – Excipient Specifications (2021)

Ezetimibe Simvastatin 10/20mg (Dr. Reddy's) – Excipient Specifications (2021)

Ezetimibe Simvastatin 10/80mg (Dr. Reddy's) – Excipient Specifications (2021)

Ezetimibe Simvastatin 10/40mg (Dr. Reddy's) – Excipient Contamination (2021)

Ezetimibe Simvastatin 10/10mg (Dr. Reddy's) – Excipient Specifications (2021)

Betaxolol Ophthalmic Solution (Akorn) – Microbial Contamination (2021)

Royal Jelly Capsules (NOW) – Metronidazole Contamination (2021)

Kids Jungamals (Pharmanex) – Undeclared Fish Allergen (2021)

Ginseng Royal Jelly (NOW) – Metronidazole Contamination (2021)

Butalbital APAP Caf Tablets (Bryant Ranch) – Incomplete Labeling (2021)

Artesunate for Injection (AMIVAS) – Sterility Concern (2021)

Potassium Chloride Extended-Release Tablets (Strides) – Dissolution Failed (2021)

Glucagon Emergency Kit (Eli Lilly) – Subpotent Medication (2021)

Liquid Vitamin D (Dr. Berg) – mold contamination (2021)

Hydroquinone Skin Bleaching Cream (Monarch) – USP Specification Failure (2021)

Testosterone Cypionate (New Vitalis) – Sterility Concern (2021)

AirDuo Digihaler 55/14 (Teva) – Subpotent Salmeterol (2021)