Recall
FDAHealthJanuary 7, 2025

PAI Holdings, LLC. dba Pharmaceutical Associates Inc — Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenv

⚠️ Superpotent; sodium benzoate preservative

Is this relevant to me?

Geography
OH
Source agency
FDA
Category
Health
Published
January 7, 2025

OH

What's affected?

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
Lot code
4B07

Additional details

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

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 4080 Bottles.

View original FDA notice →

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