Recalls / Class I
Class ID-0863-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Phenytoin
- Generic name
- Phenytoin
- Active ingredient
- Phenytoin
- Route
- Oral
- NDC
- 51672-4069
- FDA application
- ANDA040521
- Affected lot / code info
- Lot# 327874, 327876, Exp Dec/2020
Why it was recalled
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 29,172 8 Fl Oz bottles
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2020-02-07
- FDA classified
- 2020-03-02
- Posted by FDA
- 2020-03-04
- Terminated
- 2023-12-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0863-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.