D-0114-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- November 18, 2020
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 841 cartons
Product Description
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Distribution Pattern
Nationwide
Code Information
Lots: T02520, T02637, exp 02/2021