VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 337
Recalled July 15, 2020 · FDA recall D-1377-2020 · VistaPharm
Hazard
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. · FDA Class III
Units
380,700 cups
Sold at
United States including Puerto Rico
Description
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Product
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.
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →