April 2011 FDA Recall Drug by Vistapharm, Inc.
D-1658-2012 - Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume

This Class II drug recall was voluntarily initiated by Vistapharm, Inc. on April 6, 2011 for the product Drug. The FDA reported the reason for recall as defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. the viscosity and assay failures were due to the loss of moisture. the loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1658-2012

Reason for Recall
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Initiated
04-06-2011
Reported
08-29-2012
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62893
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-23-2012
Product Description About Product Description
Full technical description of the product.
Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50

Batch or Lot Expiration Information

Lot# Lot 202800, NDC 66689-035-50