Taro Pharmaceuticals U.S.A., Inc. recalls Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries L…

Recall date

February 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0863-2020

FDA classification

Class I

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Distributed Nationwide in the USA.

Why it was recalled

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

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

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1