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

Recall date

January 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0222-2025

FDA classification

Class III

Brand / firm

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Sold / distributed

OH

Why it was recalled

Superpotent; sodium benzoate preservative

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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