Reported Dec 28, 2016 · Terminated

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only,…

Impax Laboratories, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Impax Laboratories, Inc. · 31153 San Antonio Street · Hayward, CA · 94544

Is this the product you have?

  • Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only
  • Manufactured byWatson Pharma Private Ltd., Verna, Salcette Goa INDIA
  • Distributed byImpax Generics, Hayward, CA
Lot codes and dates
    • Lot Number 502240
    • expiry date 11/2017
Amount recalled
3,074 boxes (30 count boxes)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 1, 2017 · Data as of Sep 19, 7:21 PM UTC

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