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.
Reported: July 15, 2020 Initiated: June 23, 2020 #D-1377-2020
Product Description
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.
Reason for Recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 380,700 cups
- Distribution
- United States including Puerto Rico
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by VistaPharm, Inc.. Units affected: 380,700 cups.
Why was this product recalled? ▼
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Low. Recall number: D-1377-2020.
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