Class III
Drug Recall: 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
PAI Holdings, LLC. dba Pharmaceutical Associates Inc · January 7, 2025
Reason for Recall
Superpotent; sodium benzoate preservative
Distribution
OH
States Affected
OH
Quantity Affected
4080 Bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0222-2025
Status: completed
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