Class IIIReported 2025-02-12

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

Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason for Recall

Superpotent; sodium benzoate preservative

Recall Number

D-0222-2025

Classification

Class III

Status

Completed

Category

drug

Initiated

2025-01-07

Reported

2025-02-12

Distribution

OH

Code Info

Lot number 4B07, Exp Date: 2026-OCT-31

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.