FDA Drug Moderate Class II Terminated

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

Reported: August 18, 2021 Initiated: July 29, 2021 #D-0721-2021

Product Description

Reason for Recall

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

Details

Recalling Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Units Affected: a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Distribution: Distributed Nationwide in the USA
Location: Greenville, SC

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Units affected: a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case).

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 18, 2021. Severity: Moderate. Recall number: D-0721-2021.