FDA-Drug2018-12-26Class III
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
VistaPharm, Inc.
Hazard
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
4,065,550 5 ml cups
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2019Don't want to check this manually?
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