February 2020 FDA Recall Phenytoin by Taro Pharmaceuticals U.s.a., Inc.
D-0863-2020 - Resuspension Problems

This Class I drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on February 7, 2020 for the product Phenytoin. The FDA reported the reason for recall as resuspension problems. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0863-2020

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.
Initiated
02-07-2020
Reported
03-04-2020
Quantity
29,172 8 Fl Oz bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84916
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-11-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 327874, 327876, Exp Dec/2020

Affected Packages Involved in this Recall

51672-4069-1 Phenytoin
51672-4069-2 Phenytoin