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TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count...

FDA Recall #D-0489-2024 — Class II — May 2, 2024

Recall #D-0489-2024 Date: May 2, 2024 Classification: Class II Status: Terminated

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

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

23,970 Tablets

Distribution

Nationwide in the USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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