The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1053-2017·Announced 2017-08-09

VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

VistaPharm, Inc. is recalling Lactulose Solution, USP, 20 g/30 mL, packaged in 50-unit dose cups per case. The recall involves 9,945 cases of the product manufactured in Largo, Florida.

The recall was initiated because the product failed the Total Yeast/Mold Count specification, indicating microbial contamination of the non-sterile product. The affected lots are 458300 (Exp 09/2018), 462600 (Exp 07/2018), 471000 (Exp 10/2018), and 474300 (Exp 11/2018).

The product was distributed in California, Illinois, Louisiana, New Hampshire, Ohio, Pennsylvania, and South Carolina. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

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
Manufacturer
VistaPharm, Inc.
Category
Drug — Oral Solution
Hazard
Affected units
9,945

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · VistaPharm, Inc.

See all →

Same hazard · microbial contamination

See all →

Similar recalls