D-0489-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- May 2, 2024
- Termination Date
- September 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,970 Tablets
Product Description
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
Reason for Recall
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
Distribution Pattern
Nationwide in the USA
Code Information
Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523