Reported Mar 4, 2020 · Terminated
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries…
Taro Pharmaceuticals U.S.A., Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174
Is this the product you have?
Phenytoin Oral Suspension USP125 mg/5 mL potency8 fl oz (237 mL) Rx Only Mfd
- byTaro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist
- by
Taro Pharmaceuticals U.S.A. Inc. HawthorneNY 10532NDC 51672-4069-1
- Lot codes and dates
Lot# 327874327876Exp Dec/2020
- Amount recalled
- 29,172 8 Fl Oz bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Using this product could cause serious injury, illness or death — stop using it now.
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