Recall: D-0222-2025

Class III - Minor Violations

Class IIIClassification
2025-01-07Initiated
TerminatedStatus
PAI Holdings, LLC. dba PharmacFirm

Product

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

Reason

Superpotent; sodium benzoate preservative

Distribution

OH

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.