D-0471-2017 Class III Terminated
FDA drug recall D-0471-2017 was initiated by Apotex Inc. on Dec 19, 2016 and is designated Class III. Reason for recall: Superpotent Drug: Product may not meet specifications throughout shelf life. The recall status is terminated (terminated Jun 15, 2022). Affected quantity: 67,946 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 15, 2017
- Initiation Date
- Dec 19, 2016
- Termination Date
- Jun 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,946 bottles
Product description
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
Reason for recall
Superpotent Drug: Product may not meet specifications throughout shelf life.
Distribution pattern
Nationwide in the USA
Code information
Lot #: MJ7746, Exp 04/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0471-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026