Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16

Recall Number: D-1494-2020

Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Classification: Class II

Status: Terminated

Report Date: 20200819

Initiation Date: 20200804

Termination Date: 20210922

Reason for Recall

Subpotent drug: Out of specification for assay at the 15-month test interval.

Product Description

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16