Taro Pharmaceuticals U.S.A., Inc. recalls Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Is…
- Recall date
- December 20, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0833-2020
- FDA classification
- Class I
- Brand / firm
- Taro Pharmaceuticals U.S.A., Inc.
- Sold / distributed
- Nationwide in the U.S. and Puerto Rico.
Why it was recalled
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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