Apotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Recalled July 27, 2022 · FDA recall D-1285-2022 · Apotex
Hazard
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. · FDA Class II
Units
2010 bottles
Sold at
USA Nationwide
Description
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
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
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →