Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Classification
Class III
Status
Ongoing
Lot
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Amerisource Health Services LLC — Class III Recall | MedicineWatch US