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Recall Observatory FDA recall evidence

Drug product

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

D-0833-2020

December 20, 2019

Class I

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 84645
Status
Terminated
Classification
Class I
Quantity
Unavailable
Official record key
drug-enforcement:D-0833-2020

Official wording

Reason: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Code information: Lot #: 331771, Exp. June 2021

Distribution pattern: Nationwide in the U.S. and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.