May 2024 FDA Recall Drug by Remedyrepack Inc.
D-0489-2024 - Presence of Foreign Tablets

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on May 2, 2024 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0489-2024

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
Initiated
05-02-2024
Reported
05-15-2024
Quantity
23,970 Tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94567
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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