VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 337…

Recall date

June 23, 2020

Source

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

Recall number

D-1377-2020

FDA classification

Class III

Brand / firm

VistaPharm, Inc.

Sold / distributed

United States including Puerto Rico

Why it was recalled

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

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 Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.