Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reported: August 28, 2013 Initiated: July 4, 2013 #D-913-2013
Product Description
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason for Recall
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 1,707,050 cups / 5ml ea.
- Distribution
- Nationwide.
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771. Recalled by VistaPharm, Inc.. Units affected: 1,707,050 cups / 5ml ea..
Why was this product recalled? ▼
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2013. Severity: Moderate. Recall number: D-913-2013.
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