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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall involving microbial contamination of a pharmaceutical product, which meets the criteria for a Severe rating.
Plain-English summary
VistaPharm, Inc. is recalling Lactulose Solution, USP, 10 g/15 mL, packaged in 50-unit dose cups. The recall involves 6,150 cases of the product, identified by Lot # 468300 (Exp 09/2018) and Lot # 474400 (Exp 11/2018). The affected units were distributed in California, Illinois, Louisiana, New Hampshire, Ohio, Pennsylvania, and South Carolina.
The recall was initiated because the product failed the Total Yeast/Mold Count specification, indicating microbial contamination of the non-sterile product. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact VistaPharm, Inc. for further instructions or a refund.
The recalled product
- 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
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 6,150
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 (4)
- Lot #: 468300
- Exp 09/2018
- 474400
- Exp 11/2018
Distribution
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.
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