VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects
VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.
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 hazard involves potential assay and viscosity failures due to moisture loss, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
VistaPharm, Inc. is recalling Xactdose Phenytoin Oral Suspension, USP, 125mg/5 mL, supplied in 5 mL unit dose cups (NDC 66689-035-50). The recall involves Lot 202800. The product was distributed nationwide.
The recall was initiated due to a defective container lidding deformity. This defect allows the contained product to transpire, resulting in the loss of moisture. The loss of moisture causes the viscosity to increase and the assay to increase relative to the sample volume, leading to potential viscosity and assay failures.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Suspension
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 202800
- NDC 66689-035-50
Distribution
Distributed nationwide across the United States.
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