Carbamazepine Suspension
FDA Recall NDC 51672-4047
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 Carbamazepine (NDC 51672-4047). A significant event, classified as Class III, was initiated on Oct 21, 2014 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval."
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 III Terminated
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Oct 21, 2014
Nov 05, 2014
1,966 bottles
Recall Profile & Regulatory Data
Event ID
69413
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, OH, LA
Termination Date
Apr 03, 2017
Product Description
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
Batch or Lot Expiration Information
Lot# Lot 137393, exp. 10/2016
Affected Packages Involved in this Recall
51672-4041-1Product
51672-4041-2Product
51672-4041-9Product
51672-4041-0Product
51672-4050-1Product
51672-4005-1Product
51672-4005-2Product
51672-4005-3Product
51672-4123-6Product
51672-4123-1Product
51672-4123-3Product
51672-4124-6Product
51672-4124-1Product
51672-4124-3Product
51672-4125-6Product
51672-4125-1Product
51672-4125-3Product
51672-4047-9Product
51672-4047-4Product
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.
