FDA recall D-0517-2024

Rubicon Research Private Limited · Class II · drug

Product

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

Reason for recall

Presence of Foreign Substance: metal in tablet

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-05-06
Report date: 2024-06-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ambarnath, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2024