D-1285-2022 Class II Terminated
FDA drug recall D-1285-2022 was initiated by Apotex Corp. on Jul 7, 2022 and is designated Class II. Reason for recall: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. The recall status is terminated (terminated Sep 22, 2025). Affected quantity: 2010 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 27, 2022
- Initiation Date
- Jul 7, 2022
- Termination Date
- Sep 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2010 bottles
Product description
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.
Distribution pattern
USA Nationwide
Code information
Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1285-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026