Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bott...
FDA Recall #D-0222-2025 — Class III — January 7, 2025
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
Reason for Recall
Superpotent; sodium benzoate preservative
Recalling Firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc — Greenville, SC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4080 Bottles
Distribution
OH
Code Information
Lot number 4B07, Exp Date: 2026-OCT-31
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated