Product: Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Reason for recall: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recall initiated: 20170118
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated