VistaPharm Recalls Phenytoin Oral Suspension Due to Container Defects
VistaPharm is recalling specific lots of Phenytoin Oral Suspension because a lidding defect caused the product to fail stability tests for assay and viscosity.
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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
VistaPharm, Inc. is recalling 27,788 cases of Phenytoin Oral Suspension USP 125mg/5mL. The affected product is distributed nationwide and in Puerto Rico. The recall involves specific lots with expiration dates ranging from June 2014 to June 2015.
The recall was initiated due to a lidding deformity in the product containers. This defect resulted in out-of-specification results for assay and viscosity at the 12-month stability timepoint. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Anticonvulsant
- Affected units
- 27,788
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 (12)
- Lots #'s: 268200
- Exp 06/14
- 274600
- Exp 08/14
- 279500
- Exp 09/14
- 290700
- Exp 12/14
- 296700
- Exp 02/15
- 305100
- Exp 06/15
Distribution
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