VistaPharm, Inc. recalls NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)…

Recall date

September 25, 2020

Source

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

Recall number

D-0019-2021

FDA classification

Class III

Brand / firm

VistaPharm, Inc.

Sold / distributed

Distributed Nationwide in the USA including Puerto Rico

Why it was recalled

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

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

What was recalled

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,