traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plain
Summary
The FDA issued a Class II for traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distribut by Rubicon Research Private Limited. Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol.
Details
Source
Drug Recall
External ID
D-0487-2024
Action Date
2024-05-15
Status
Ongoing
Category
drug
Product Description
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
Lot/Code Info: Lot #: 230774Hl, Exp 4/30/2026
Quantity Affected: 2,592 1000-count Bottles
Reason for Recall
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-26
Company
Ambarnath, N/A
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.
Rubicon Research Private Limited has 4 FDA actions in our database, including 4 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 (Rubicon Research Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rubicon Research Private Limited have FDA actions?
Rubicon Research Private Limited has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0487-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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