← FDA ENFORCEMENT
D-0487-2024Class II

Rubicon Research Private Limited

Recalling firm
Rubicon Research Private Limited
Product type
Drug
Status
Ongoing
Report date
2024-05-15
Distribution
Nationwide in the USA
Firm state
N/A
Product quantity
2,592 1000-count Bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

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

Code / lot info

Lot #: 230774Hl, Exp 4/30/2026

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.