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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a defect that could lead to significant product failure.
Plain-English summary
VistaPharm, Inc. is recalling Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups. The recall involves 27,221 unit dose cups distributed nationwide under NDC 66689-036-50. The affected lots are 210900, 214000, 220100, 224800, 228700, and 232800.
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.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Suspension
- Affected units
- 27,221
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 (6)
- Lot #'s 210900
- 214000
- 220100
- 224800
- 228700
- 232800
Distribution
Distributed nationwide across the United States.
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