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

FDA recall notice · announced November 25, 2020 · Apotex

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Quantity: a)552 bottles; b) 3192 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0106-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.