Drug product
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
D-0626-2026
Product summary
- Event
- Event 99200
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31,392 60-count bottles
- Official record key
drug-enforcement:D-0626-2026
Official wording
Reason: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Code information: Lot: A253999, A254000, Expires: 09/30/2027.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets