VistaPharm, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000
Recalled June 7, 2017 · FDA recall D-0869-2017 · VistaPharm
Hazard
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. · FDA Class III
Units
2,208,500 cups/18696 bottles
Sold at
Nationwide in the US and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Product
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →