Drug product
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
D-0245-2017
Product summary
- Firm
- Apotex Corp.
- Event
- Event 75964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,179 bottles (1,317,900 tablets)
- Official record key
drug-enforcement:D-0245-2017
Official wording
Reason: CGMP Deviations
Code information: Lot #: KW8378; Exp. Date 05/17.
Distribution pattern: United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations