Torsemide Tablets recalled over manufacturing violations

Recall date

December 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apotex Corp. recalls Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, M…

Recall number

D-0244-2017

FDA classification

Class II

Brand / firm

Apotex Corp.

Sold / distributed

United States

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01