FDA recall D-0863-2020

Taro Pharmaceuticals U.S.A., Inc. · Class I · drug

Product

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.

Distribution

Distributed Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2020-02-07
Report date: 2020-03-04
Termination date: 2023-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2020