Drug product
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
D-0459-2025
Product summary
- Event
- Event 96840
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,946 500-count bottles
- Official record key
drug-enforcement:D-0459-2025
Official wording
Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Code information: Batch 2405014780, Exp. Date: Sep. 30, 2027
Distribution pattern: Distributed Nationwide and in PR
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets