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

Recall #D-0222-2025 · 01/07/2025

Class III: Low Risk

Recall Details

Recall Number: D-0222-2025
Classification: Class III
Product Type: Drug
Recalling Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Status: Completed
Date Initiated: 01/07/2025
Location: Greenville, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4080 Bottles

Reason for Recall

Superpotent; sodium benzoate preservative

Product Description

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

Distribution Pattern

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

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.
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.