Multi-event June 2017 FDA Recall Drug by Vistapharm, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Vistapharm, Inc. on June 26, 2017 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed in CA, IL, LA, NH, OH, PA, SC and the recall is currently terminated.

Reported Recall Events

D-1053-2017 TERMINATED D-1052-2017 TERMINATED

Recall Number: D-1053-2017

Reason for Recall
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Initiated
06-26-2017
Reported
08-09-2017
Quantity
9945 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77638
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.
CA, IL, LA, NH, OH, PA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

Batch or Lot Expiration Information

Lot# : 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018

Recall Number: D-1052-2017

Reason for Recall
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Initiated
06-26-2017
Reported
08-09-2017
Quantity
6150 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77638
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.
CA, IL, LA, NH, OH, PA, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

Batch or Lot Expiration Information

Lot# : 468300, Exp 09/2018; 474400, Exp 11/2018