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.
What this means for you
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
- 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
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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