July 2013 FDA Recall Drug by Vistapharm, Inc.
D-913-2013 - Failed Impurites/Degradation Specifications

This Class II drug recall was voluntarily initiated by Vistapharm, Inc. on July 4, 2013 for the product Drug. The FDA reported the reason for recall as failed impurites/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-913-2013

Reason for Recall
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Initiated
07-04-2013
Reported
08-28-2013
Quantity
1,707,050 cups / 5ml ea.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65756
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2014
Product Description About Product Description
Full technical description of the product.
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

Batch or Lot Expiration Information

Lot# 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.