Recall Enforment Report D-1285-2022

Drug Recall Enforcement Report Class II voluntary initiated by Apotex Corp., originally initiated on 07-07-2022 for the product 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 The product was recalled due to failed dissolution specifications: oos for dissolution at the 12-month stability time point.. The product was distributed nationwide and the recall is currently completed.

Field Name Field Value
Event ID 90569 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1285-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 2010 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 07-27-2022
Recall Initiation Date 07-07-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Apotex Corp.
Code Info Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 60505-3075-3; 60505-3075-8; 60505-2673-3; 60505-2673-8; 60505-2673-0; 60505-2674-3; 60505-2674-8; 60505-2674-0; 60505-2675-3; 60505-2675-8; 60505-2675-0; 60505-2676-3; 60505-2676-8; 60505-2676-0; 60505-2677-3; 60505-2677-8; 60505-2677-0
Status Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
60505-2673Aripiprazole AripiprazoleTabletOralApotex CorpHuman Prescription Drug
60505-2674Aripiprazole AripiprazoleTabletOralApotex CorpHuman Prescription Drug
60505-2675Aripiprazole AripiprazoleTabletOralApotex CorpHuman Prescription Drug
60505-2676Aripiprazole AripiprazoleTabletOralApotex CorpHuman Prescription Drug
60505-3075Aripiprazole AripiprazoleTabletOralApotex CorpHuman Prescription Drug