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
D-0222-2025
Product summary
- Event
- Event 96119
- Status
- Completed
- Classification
- Class III
- Quantity
- 4080 Bottles
- Official record key
drug-enforcement:D-0222-2025
Official wording
Reason: Superpotent; sodium benzoate preservative
Code information: Lot number 4B07, Exp Date: 2026-OCT-31
Distribution pattern: OH
Derived failure modes
-
Potency or specification failure
Superpotent