D-0244-2017 Class II Terminated
FDA drug recall D-0244-2017 was initiated by Apotex Corp. on Dec 14, 2016 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Jun 15, 2022). Affected quantity: 35,819 bottles (358,190,000 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Dec 14, 2016
- Termination Date
- Jun 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,819 bottles (358,190,000 tablets)
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
Distribution Pattern
United States
Code Information
Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0244-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026