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)
Recalled October 14, 2020 · FDA recall D-0019-2021 · VistaPharm
Hazard
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot · FDA Class III
Units
14,244 16 oz bottles
Sold at
Distributed Nationwide in the USA including Puerto Rico
Description
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Product
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,
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →