Recalls / Class II
Class IID-0106-2021
Product
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
- Affected lot / code info
- a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
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
- a)552 bottles; b) 3192 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-11
- FDA classified
- 2020-11-24
- Posted by FDA
- 2020-11-25
- Terminated
- 2021-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0106-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.