FDAJanuary 7, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Superpotent; sodium benzoate preservative

What to do

FDA enforcement status: Completed

Brands named

pai holdings llc dba pharmaceutical associatespaipai holdings

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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