FDA recall D-0245-2017

Apotex Corp. · Class II · drug

Product

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Reason for recall

CGMP Deviations

Distribution

United States

Key facts

Status: Terminated
Initiation date: 2016-12-14
Report date: 2017-01-11
Termination date: 2022-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2017