FDA recall D-0487-2024

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-04-26

Report date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ambarnath, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2024