Drug product
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
D-0536-2026
Product summary
- Event
- Event 98884
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 63,500 tablets
- Official record key
drug-enforcement:D-0536-2026
Official wording
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Code information: Lot#: 1027583, Exp 09/30/2027
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.