PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 15, 2024 Initiated: April 26, 2024 #D-0487-2024

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

Reason for Recall

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

Details

Units Affected
2,592 1000-count Bottles
Distribution
Nationwide in the USA
Location
Ambarnath, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Rubicon Research Private Limited. Units affected: 2,592 1000-count Bottles.
Why was this product recalled?
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Which agency issued this recall?
This recall was issued by the FDA Drug on May 15, 2024. Severity: Moderate. Recall number: D-0487-2024.