PAI Holdings, LLC. dba Pharmaceutical Associates Inc: Drug Recall

Recall #D-0721-2021 · 07/29/2021

Class II: Risk

Recall Details

Recall Number: D-0721-2021
Classification: Class II
Product Type: Drug
Recalling Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Status: Terminated
Date Initiated: 07/29/2021
Location: Greenville, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)

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

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Class III: Low Risk 01/07/2025

Superpotent; sodium benzoate preservative
Class II: Risk 07/29/2021

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class II: Risk 07/29/2021

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

View all recalls by PAI Holdings, LLC. dba Pharmaceutical Associates Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.