PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 11, 2017 Initiated: December 14, 2016 #D-0245-2017

Product Description

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

Details

Recalling Firm
Apotex Corp.
Units Affected
13,179 bottles (1,317,900 tablets)
Distribution
United States
Location
Weston, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Apotex Corp.. Units affected: 13,179 bottles (1,317,900 tablets).
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2017. Severity: Moderate. Recall number: D-0245-2017.