Drug product
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
D-0535-2026
Product summary
- Event
- Event 98856
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,620 bottles
- Official record key
drug-enforcement:D-0535-2026
Official wording
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Code information: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.