Recalls / Class III
Class IIID-0471-2017
Product
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
- Affected lot / code info
- Lot #: MJ7746, Exp 04/17
Why it was recalled
Superpotent Drug: Product may not meet specifications throughout shelf life.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 67,946 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2016-12-19
- FDA classified
- 2017-02-09
- Posted by FDA
- 2017-02-15
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0471-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.