Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0863-2020

February 07, 2020

Class I

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 84916
Status
Terminated
Classification
Class I
Quantity
29,172 8 Fl Oz bottles
Official record key
drug-enforcement:D-0863-2020

Official wording

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

Code information: Lot# 327874, 327876, Exp Dec/2020

Distribution pattern: Distributed Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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