FDA-Drug2017-02-08Class II
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
VistaPharm, Inc.
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Sold states
Nationwide
Affected count
67,955 bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0457-2017Don't want to check this manually?
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