Recall Enforment Report D-0049-2015

Drug Recall Enforcement Report Class III voluntary initiated by Taro Pharmaceuticals U.S.A., Inc., originally initiated on 10-21-2014 for the product 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. The product was recalled due to 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.. The product was distributed in Il, Oh, La and the recall is currently terminated.

Field Name	Field Value
Event ID	69413 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0049-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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	IL, OH, LA 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	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.
Reason For Recall	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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,966 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	11-05-2014
Recall Initiation Date	10-21-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-03-2017 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	Taro Pharmaceuticals U.S.A., Inc.
Code Info	Lot 137393, exp. 10/2016 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	51672-4041-1; 51672-4041-2; 51672-4041-9; 51672-4041-0; 51672-4050-1; 51672-4005-1; 51672-4005-2; 51672-4005-3; 51672-4123-6; 51672-4123-1; 51672-4123-3; 51672-4124-6; 51672-4124-1; 51672-4124-3; 51672-4125-6; 51672-4125-1; 51672-4125-3; 51672-4047-9
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.

Recalled Products