VistaPharm, Inc. recalls Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16
Recalled February 8, 2017 · FDA recall D-0457-2017 · VistaPharm
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. · FDA Class II
Units
67,955 bottles
Sold at
Nationwide
Description
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), 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 →