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.

Recall Number: D-1377-2020

Firm: VistaPharm, Inc.

Classification: Class III

Status: Terminated

Report Date: 20200715

Initiation Date: 20200623

Termination Date: 20220928

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

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.