Drug 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
D-0106-2021
Product summary
- Firm
- Apotex Corp.
- Event
- Event 86736
- Status
- Terminated
- Classification
- Class II
- Quantity
- a)552 bottles; b) 3192 bottles
- Official record key
drug-enforcement:D-0106-2021
Official wording
Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Code information: a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification