Drug product
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
D-0541-2024
Product summary
- Event
- Event 94642
- Status
- Ongoing
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0541-2024
Official wording
Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Code information: Lot: 23132611, Exp 07/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets