May 2017 FDA Recall Drug by Vistapharm, Inc.
D-0869-2017 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Vistapharm, Inc. on May 17, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0869-2017

Reason for Recall
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Initiated
05-17-2017
Reported
06-07-2017
Quantity
2,208,500 cups/18696 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77319
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2020
Product Description About Product Description
Full technical description of the product.
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.

Batch or Lot Expiration Information

Lot# a)
Lot# : 431300, Exp. 01/2018; b)
Lot# : 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c)
Lot# : 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.