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
Reported: March 4, 2020 Initiated: February 7, 2020 #D-0863-2020
Product Description
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
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.
Details
- Recalling Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Units Affected
- 29,172 8 Fl Oz bottles
- Distribution
- Distributed Nationwide in the USA.
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 29,172 8 Fl Oz bottles.
Why was this product recalled? ▼
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 4, 2020. Severity: Critical. Recall number: D-0863-2020.
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