TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 7051
Summary
The FDA issued a Class II for TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824 by RemedyRepack Inc.. Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tram.
Details
Source
Drug Recall
External ID
D-0489-2024
Action Date
2024-05-15
Status
Terminated
Category
drug
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
Lot/Code Info: Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
Quantity Affected: 23,970 Tablets
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
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-02
Company
Indiana, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RemedyRepack Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RemedyRepack Inc. have FDA actions?
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0489-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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