Phenytoin Oral Suspension recalled over manufacturing violations

Recall date

January 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

VistaPharm, Inc. recalls Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm,…

Recall number

D-0460-2017

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.