Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 605
Recalled November 25, 2020 · FDA recall D-0106-2021 · Apotex
Hazard
Failed Dissolution Specifications: Out of specification for dissolution. · FDA Class II
Units
a)552 bottles; b) 3192 bottles
Sold at
Distributed Nationwide in the USA
Description
Failed Dissolution Specifications: Out of specification for dissolution.
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
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →