Class IITerminated

TraMADol HCl 50 mg Tablet recall

FDA recall D-0489-2024 · initiated May 2, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

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

Details

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
Recalling company: RemedyRepack Inc.
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: May 2, 2024
FDA report date: May 15, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0489-2024 ↗

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