TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablets
RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving contamination where a different medication (baclofen) was found in tramadol bottles. Although no illnesses or injuries have been reported, the presence of foreign medication represents a significant risk of harm if ingested.
Plain-English summary
RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets after a baclofen tablet was found in a 1000-count tramadol bottle. A pharmacist discovered the foreign tablet in the bottle.
Affected products include 30-count, 90-count, and 180-count blister packs distributed nationwide. Approximately 23,970 tablets are affected, with lot numbers J0732085-101023, B2546618-100523, and B2546541-100523.
If you have received any of the affected blister packs, do not use the product and contact your pharmacy or pharmacist. Taking the wrong medication could pose serious health risks.
The recalled product
- 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.…
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription Tablet
- Affected units
- 23,970
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots#: (a)J0732085-101023
- Exp (b) B2546618-100523
- Exp (c) B2546541-100523
Distribution
Distributed nationwide across the United States.
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