FDA Recall Clozapine

The last Recall Enforcement Report for Clozapine with NDC 65862-844 was initiated on 06-12-2020 as a Class II recall due to presence of foreign tablet: consumer complaint of clozapine tablets 50mg being present in 500 count bottles of clozapine tablets usp 100mg. The latest recall number for this product is D-1370-2020 and the recall is currently terminated as of 12-21-2022 .

Recall Number D-1370-2020

Field Name	Field Value
Event ID	85852 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1370-2020 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	U.S.A. 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	Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Reason For Recall	Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1440 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	07-01-2020
Recall Initiation Date	06-12-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	12-21-2022 What is the Date Terminated? The date that FDA terminated 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: CZSC20003-A, Exp 1/2022 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	65862-844-01; 65862-844-05; 65862-844-10; 65862-844-78; 65862-845-01; 65862-845-05; 65862-845-10; 65862-845-78; 65862-846-01; 65862-846-05; 65862-846-10; 65862-846-78; 65862-847-01; 65862-847-05; 65862-847-10; 65862-847-78
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
	View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.