Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

Recall Number: D-1378-2020

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 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.