Product: 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.
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