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