Drug product
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
D-0533-2026
Product summary
- Event
- Event 98791
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 44865 bottles
- Official record key
drug-enforcement:D-0533-2026
Official wording
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Code information: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.