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

FDA recall notice · announced July 27, 2022 · Apotex

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

The 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.

Notes

Distribution: USA Nationwide
Lot/code information: Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Quantity: 2010 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1285-2022)

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