October 2013 FDA Recall Drug by Vistapharm, Inc.
D-342-2014 - Defective Container

This Class II drug recall was voluntarily initiated by Vistapharm, Inc. on October 15, 2013 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-342-2014

Reason for Recall
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Initiated
10-15-2013
Reported
12-18-2013
Quantity
27,788 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66945
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VistaPharm, 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.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2016
Product Description About Product Description
Full technical description of the product.
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

Batch or Lot Expiration Information

Lot# Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15