Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

Recall Number: D-913-2013

Firm: VistaPharm, Inc.

Classification: Class II

Status: Terminated

Report Date: 20130828

Initiation Date: 20130704

Termination Date: 20140804

Reason for Recall

Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

Product Description

Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771