FDAClass IIAugust 9, 2017

Lactulose Solution recall: Sterility Concern

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…

Why was Lactulose Solution recalled?

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
VistaPharm, Inc.
Quantity
9945 cases
Distribution
CA, IL, LA, NH, OH, PA, SC
Recall date
August 9, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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