Class III

Drug Recall: 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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc · January 7, 2025

Reason for Recall

Superpotent; sodium benzoate preservative

Distribution

OH

States Affected

OH

Quantity Affected

4080 Bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0222-2025

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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