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

Recall Number: D-0222-2025

Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Classification: Class III

Status: Terminated

Report Date: 20250212

Initiation Date: 20250107

Termination Date: 20260725

Reason for Recall

Superpotent; sodium benzoate preservative

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

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