CODEINE PHOSPHATE Recall D-0222-2025
Description: 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
CODEINE PHOSPHATE Recall D-0222-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0222-2025 |
| Event ID | 96119 |
| Brand | GUAIFENESIN AND CODEINE PHOSPHATE |
| Generic Name | GUAIFENESIN AND CODEINE PHOSPHATE |
| Manufacturer | GUAIFENESIN AND CODEINE PHOSPHATE |
| Original Package? | 1 |
| Active Substance | CODEINE PHOSPHATE GUAIFENESIN |
| Drug Route | ORAL |
| Distribution | OH |
| Quantity | 4080 Bottles |
| Recall Reason | Superpotent; sodium benzoate preservative |
| Drug Classification | Class III |
| Drug Code Info | 20250212 |
| Product NDC | 0121-0775 0121-1775 0121-1550 |
| Product NUI | N0000193956 N0000008867 N0000009560 |
| Pharma Class (PE) | Decreased Respiratory Secretion Viscosity [PE] |
| Pharma Class (EPC) | Expectorant [EPC] |
| Recall Initiation Date | 20250107 |
| Report Date | 20250212 |
| Classification Date | 20250204 |
| Address | 1700 Perimeter Rd Greenville, SC 29605-5252 United States |
| Recalling Firm | PAI Holdings, LLC. dba Pharmaceutical Associates Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | GSL05Y1MN6 495W7451VQ |
| Drug Application Number | M012 |
| Structured Product Labeling (SPL ID) | 2175415b-f07e-50a6-e063-6394a90acabe |
| Structured Product Labeling (SPL Set ID) | 88d0994c-4270-4408-8837-bd97510b2118 |
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