Reported Jan 28, 2015 · Terminated

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

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201

Is this the product you have?

  • LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only
  • Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
Lot codes and dates
  • Lot Number3038124
  • Expiration Date1/14
  • NDC51079-866-20
Amount recalled
3,993 cartons

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 9, 2015 · Data as of Sep 19, 5:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.