Drug recall D-0487-2024

Class II Ongoing reported May 15, 2024

Product

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Rubicon Research Private Limited, Ambarnath, N/A
Quantity
2,592 1000-count Bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
April 26, 2024

Related products