Class I
Terminated
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
- Recall Initiated
- February 7, 2020
- Posted
- March 4, 2020
- Recall Number
- D-0863-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 29,172 8 Fl Oz bottles
- Firm Location
- Hawthorne, NY, United States
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.
Distribution
Distributed Nationwide in the USA.
Lot / Code Info
Lot# 327874, 327876, Exp Dec/2020
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