Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontari...
FDA Recall #D-0244-2017 — Class II — December 14, 2016
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
35,819 bottles (358,190,000 tablets)
Distribution
United States
Code Information
Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated