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: terminated

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.