Multi-event June 2020 FDA Recall Drug by Vistapharm, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Vistapharm, Inc. on June 23, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation products; presence of an impurity peak that exceeds the approved specification.. The product was distributed in United States including Puerto Rico and the recall is currently terminated.

Reported Recall Events

D-1378-2020 TERMINATED D-1377-2020 TERMINATED

Recall Number: D-1378-2020

Reason for Recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Initiated
06-23-2020
Reported
07-15-2020
Quantity
14,760 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85888
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.
United States including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

Batch or Lot Expiration Information

Lot# 639000, Exp. 10/31/2021

Recall Number: D-1377-2020

Reason for Recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Initiated
06-23-2020
Reported
07-15-2020
Quantity
380,700 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85888
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.
United States including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

Batch or Lot Expiration Information

Lot# : a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.