← FDA ENFORCEMENT
D-0489-2024Class II

RemedyRepack Inc.

Recalling firm
RemedyRepack Inc.
Product type
Drug
Status
Terminated
Report date
2024-05-15
Distribution
Nationwide in the USA
Firm state
PA
Product quantity
23,970 Tablets
Initiated by
Voluntary: Firm initiated
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

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

Code / lot info

Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.