Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605

Recall Number: D-0721-2021

Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Classification: Class II

Status: Terminated

Report Date: 20210818

Initiation Date: 20210729

Termination Date: 20221202

Reason for Recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Product Description

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605