Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 3...
FDA Recall #D-0106-2021 — Class II — November 11, 2020
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.
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a)552 bottles; b) 3192 bottles
Distribution
Distributed Nationwide in the USA
Code Information
a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated