The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0460-2017·Announced 2017-02-08

VistaPharm Recalls Phenytoin Oral Suspension Due to Water Contamination

VistaPharm is recalling Phenytoin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

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 involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the presence of a pathogen (Burkholderia cepacia) in a drug product under a Class II classification warrants a Severe rating as it exceeds the 'theoretical' threshold of High when combined with the agency's formal Class II designation for a contaminated drug.

Plain-English summary

VistaPharm, Inc. is recalling Phenytoin Oral Suspension, USP 100 mg/4 mL, 50 unit dose cups. The recall involves 12,059 unit dose cups distributed nationwide. The specific lots affected are Lot No. 428700 (Exp. 11/17) and Lot No. 409500 (Exp. 06/17).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. This is a prescription-only medication.

Patients and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II.

The recalled product

Product
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
Manufacturer
VistaPharm, Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
12,059

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. 428700 (Exp. 11/17)
  • 409500 (Exp. 06/17)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 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.

See all 11 products in this recall →

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