Drug product
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
D-0244-2017
Product summary
- Firm
- Apotex Corp.
- Event
- Event 75964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,819 bottles (358,190,000 tablets)
- Official record key
drug-enforcement:D-0244-2017
Official wording
Reason: CGMP Deviations
Code information: Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17.
Distribution pattern: United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations