Product: 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.
Recall initiated: 20200623
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated