D-0537-2026 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- May 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225,000 tablets
Product Description
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 for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution Pattern
USA Nationwide
Code Information
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027