FDAFDA · Food and drugs·Recall number D-0863-2020
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
Published March 4, 2020 · Recall initiated: February 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PHENYTOIN
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Distributor
- Distributed Nationwide in the USA.
- UPC
- 0351672406929
- Lot
- Lot# 327874, 327876, Exp Dec/2020
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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