Recalls / Class II
Class IID-0489-2024
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
- Affected lot / code info
- Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
Why it was recalled
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
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 23,970 Tablets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-05-02
- FDA classified
- 2024-05-08
- Posted by FDA
- 2024-05-15
- Terminated
- 2024-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0489-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.