Drug recall D-0863-2020

Class I Terminated reported Mar 4, 2020

Product

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

Reason for recall

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

Lots and codes

Lot# 327874, 327876, Exp Dec/2020

Recall details

Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Quantity
29,172 8 Fl Oz bottles
Distribution
Distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
February 7, 2020
Terminated
December 11, 2023

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