FDA Recall D-0863-2020
Taro Pharmaceuticals U.S.A., Inc. · Hawthorne, NY
Class I — life-threatening Terminated 1403 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0863-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA.
- Recall initiated
- 2020-02-07
- Classified by FDA Center
- 2020-03-02
- FDA published
- 2020-03-04
- Terminated
- 2023-12-11
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Firm location
- Hawthorne, NY
Drug identification
- Brand name(s)
- PHENYTOIN
- Generic name(s)
- PHENYTOIN
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
51672-4069- Route(s)
- ORAL