Drug product
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
D-0534-2026
Product summary
- Event
- Event 98856
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 8,526 bottles
- Official record key
drug-enforcement:D-0534-2026
Official wording
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Code information: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.