D-0106-2021 Class II Terminated
FDA drug recall D-0106-2021 was initiated by Apotex Corp. on Nov 11, 2020 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution. The recall status is terminated (terminated Aug 11, 2021). Affected quantity: a)552 bottles; b) 3192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 25, 2020
- Initiation Date
- Nov 11, 2020
- Termination Date
- Aug 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a)552 bottles; b) 3192 bottles
Product Description
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0106-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026