VistaPharm, Inc. recalls NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose
Recalled December 26, 2018 · FDA recall D-0348-2019 · VistaPharm
Hazard
Failed Impurities/Degradation Specifications:Out of specification for impurities. · FDA Class III
Units
4,065,550 5 ml cups
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Product
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →