Drug 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
D-1285-2022
Product summary
- Firm
- Apotex Corp.
- Event
- Event 90569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2010 bottles
- Official record key
drug-enforcement:D-1285-2022
Official wording
Reason: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Code information: Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications