Recalls / Class II
Class IID-0245-2017
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
- Affected lot / code info
- Lot #: KW8378; Exp. Date 05/17.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 13,179 bottles (1,317,900 tablets)
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2016-12-14
- FDA classified
- 2017-01-02
- Posted by FDA
- 2017-01-11
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.