FDA-Drug2017-06-07Class III
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.
VistaPharm, Inc.
Hazard
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Sold states
Nationwide in the US and Puerto Rico
Affected count
2,208,500 cups/18696 bottles
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2017Don't want to check this manually?
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