VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Us
Recalled July 15, 2020 · FDA recall D-1378-2020 · VistaPharm
Hazard
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. · FDA Class III
Units
14,760 bottles
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 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →