Recalls / Class II
Class IID-1285-2022
Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
- Affected lot / code info
- Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Why it was recalled
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
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
- 2010 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-07-07
- FDA classified
- 2022-07-21
- Posted by FDA
- 2022-07-27
- Terminated
- 2025-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1285-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.