Drug recall D-1285-2022

Class II Terminated reported Jul 27, 2022

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

Reason for recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Lots and codes

Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
2010 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 7, 2022
Terminated
September 22, 2025