VistaPharm, Inc. recalls NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose…

Recall date

November 30, 2018

Source

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

Recall number

D-0348-2019

FDA classification

Class III

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications:Out of specification for impurities.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771