D-0536-2026 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
- 63,500 tablets
Product Description
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Reason for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution Pattern
USA Nationwide
Code Information
Lot#: 1027583, Exp 09/30/2027