VistaPharm Recalls Lactulose Solution Due to Bacterial Contamination
VistaPharm is recalling Lactulose Solution, USP, 10 g/15 mL, because bulk solution tested positive for Burkholderia cepacia bacteria.
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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant contamination risks like microbial presence.
Plain-English summary
VistaPharm, Inc. is recalling Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01). The product is packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50) and is available by prescription only. The recall involves 1,497 cases of Lot No. 378300 with an expiration date of 11/16.
The recall was initiated because the bulk solution tested positive for the presence of the bacteria Burkholderia cepacia. This is a microbial contamination issue affecting non-sterile products. The affected product was distributed nationwide.
Patients and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 1,497
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 (2)
- Lot No. 378300
- Exp 11/16
Distribution
Distributed nationwide across the United States.
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