Drug product
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
D-0489-2024
Product summary
- Event
- Event 94567
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,970 Tablets
- Official record key
drug-enforcement:D-0489-2024
Official wording
Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Code information: Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets