Lamotrigine Tablet
FDA Recall NDC 29300-113
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 Lamotrigine (NDC 29300-113). A significant event, classified as Class III, was initiated on Aug 19, 2016 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets."
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
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Aug 19, 2016
Oct 05, 2016
368 bottles
Recall Profile & Regulatory Data
Event ID
75205
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Unichem Pharmaceuticals Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 07, 2017
Product Description
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Batch or Lot Expiration Information
Lot# : GLEH 16003, Exp 03/31/18
Affected Packages Involved in this Recall
29300-111-01Product
29300-111-05Product
29300-111-10Product
29300-112-01Product
29300-112-05Product
29300-112-10Product
29300-113-16Product
29300-113-05Product
29300-113-10Product
29300-114-16Product
29300-114-05Product
29300-114-10Product
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.
