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
Reported: December 26, 2018 Initiated: November 30, 2018 #D-0348-2019
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 4,065,550 5 ml cups
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by VistaPharm, Inc.. Units affected: 4,065,550 5 ml cups.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Low. Recall number: D-0348-2019.
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