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Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: results slightly under spec at at 9-months.

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Class IIILow

FDAFeb 1, 2024Nationwide• Amerisource Health Services LLC

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Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Glimepiride Tablets 1mg (Dr. Reddy's) – Tablet Misprint (2024)

Glimepiride Tablets 1mg 500-count (Dr. Reddy's) – Tablet Misprint (2024)

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Tropicamide/Cyclopentolate Drops (Fagron) – labeling mix-up (2023)

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Synthroid Levothyroxine Tablets (AbbVie) – Incorrect Barcode (2023)

Methotrexate Tablets (West-Ward Columbus) – surface defect (2023)

Trandolapril/Verapamil Tablets (Glenmark) – subpotent medication (2023)

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

PANCREAZE Digestive Enzyme Capsules (Vivus) – Stability Failure (2023)

Tranexamic Acid Tablets (AVKARE) – Conductivity Specification (2023)

Lidocaine Patch (Bryant Ranch) – Labeling Error (2023)

Epinephrine Kit (Focus Health Group) – Incorrect Labeling (2023)

Mektovi 15mg Tablets (Pfizer) – Incorrect Expiration (2023)

Evamist (Padagis) – content uniformity failure (2023)

Atropine Sulfate Eye Solution (Akorn) – Failed Stability (2023)