FDA-Drug2020-03-04Class I
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
Taro Pharmaceuticals U.S.A., Inc.
Hazard
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Sold states
Distributed Nationwide in the USA.
Affected count
29,172 8 Fl Oz bottles
Manufactured in
3 Skyline Dr, N/A, Hawthorne, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2020Don't want to check this manually?
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