FDA recall D-0222-2025
PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Class III · drug
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
Reason for recall
Superpotent; sodium benzoate preservative
Distribution
OH
Key facts
- Status
- Completed
- Initiation date
- 2025-01-07
- Report date
- 2025-02-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Greenville, SC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2025