The last Recall Enforcement Report for Lamotrigine with NDC 13668-339 was initiated on 09-11-2018 as a Class II recall due to failed dissolution specifications: out of specification for dissolution test (buffer stage) at the 5-hour time point during stability testing. The latest recall number for this product is D-1204-2018 and the recall is currently terminated as of 09-04-2020 .
Recall Number D-1204-2018
| Field Name |
Field Value |
| Event ID |
80985 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-1204-2018 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 |
Nationwide USA 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 |
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30 |
| Reason For Recall |
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
15,384 30-count 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 |
09-26-2018 |
| Recall Initiation Date |
09-11-2018 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Termination Date |
09-04-2020 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 |
Torrent Pharma Inc. |
| Code Info |
Lot: BFR5D002 EXP 11-2019 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 |
13668-339-30; 13668-339-01; 13668-339-05; 13668-340-30; 13668-340-01; 13668-340-05; 13668-341-30; 13668-341-01; 13668-341-05; 13668-342-30; 13668-342-01 |
| 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.