FDAClass IIJanuary 28, 2015

Lamotrigine Tablets recall: CGMP Deviations

LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals…

Why was Lamotrigine Tablets recalled?

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;

Product
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals…
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Quantity
3,993 cartons
Distribution
Nationwide and Puerto Rico.
Recall date
January 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls