September 2020 FDA Recall Drug by Vistapharm, Inc.
D-0019-2021 - Failed Impurties/Degradation Specifications
This Class III drug recall was voluntarily initiated by Vistapharm, Inc. on September 25, 2020 for the product Drug. The FDA reported the reason for recall as failed impurties/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0019-2021
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
09-25-2020
10-14-2020
14,244 16 oz bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA including Puerto Rico
09-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Batch or Lot Expiration Information
Lot# Lots: 638800 Exp 10/21
