FDA-Drug2020-07-15Class III
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
VistaPharm, Inc.
Hazard
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Sold states
United States including Puerto Rico
Affected count
380,700 cups
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1377-2020Don't want to check this manually?
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