Drug recall D-0222-2025
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
Lots and codes
Lot number 4B07, Exp Date: 2026-OCT-31
Recall details
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc, Greenville, SC
- Quantity
- 4080 Bottles
- Distribution
- OH
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 7, 2025
- Terminated
- July 25, 2026
Related products
- Guaifenesin and Codeine Phosphate – drug information
- NDC 0121-1550 Guaifenesin and Codeine Phosphate · Guaifenesin 200 mg/10mL; Codeine Phosphate 20 mg/10mL · PAI Holdings, LLC
- NDC 0121-0775 Guaifenesin and Codeine Phosphate · Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL · PAI Holdings, LLC
- NDC 0121-1775 Guaifenesin and Codeine Phosphate · Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL · PAI Holdings, LLC