Clozapine Tablet
FDA Recall NDC 65862-844
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clozapine (NDC 65862-844). A significant event, classified as Class II, was initiated on Jun 12, 2020 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Jun 12, 2020
Jul 01, 2020
1440 bottles
Recall Profile & Regulatory Data
Event ID
85852
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Dec 21, 2022
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
Batch or Lot Expiration Information
Lot# : CZSC20003-A, Exp 1/2022
Affected Packages Involved in this Recall
65862-844-01Product
65862-844-05Product
65862-844-10Product
65862-844-78Product
65862-845-01Product
65862-845-05Product
65862-845-10Product
65862-845-78Product
65862-846-01Product
65862-846-05Product
65862-846-10Product
65862-846-78Product
65862-847-01Product
65862-847-05Product
65862-847-10Product
65862-847-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
