COLCHICINE Recall D-0187-2025
Description: Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
COLCHICINE Recall D-0187-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0187-2025 |
| Event ID | 96026 |
| Brand | COLCHICINE |
| Generic Name | COLCHICINE |
| Manufacturer | COLCHICINE |
| Original Package? | 1 |
| Active Substance | COLCHICINE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 96 Bottles |
| Recall Reason | Out of specification observed during the accelerated stability conditions for the 30 count bottles. |
| Drug Classification | Class II |
| Drug Code Info | 20250115 |
| Product NDC | 70010-001 |
| Product NUI | N0000193949 M0000713 |
| Drug UPC | 0370010001039 |
| Pharma Class (EPC) | Alkaloid [EPC] |
| Pharma Class (CS) | Alkaloids [CS] |
| Recall Initiation Date | 20241218 |
| Report Date | 20250115 |
| Classification Date | 20250107 |
| Address | 3701 Concorde Pkwy Chantilly, VA 20151-1126 United States |
| Recalling Firm | Granules Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | SML2Y3J35T |
| Drug Application Number | ANDA210757 |
| Structured Product Labeling (SPL ID) | 2045e2e7-d632-e3d4-e063-6394a90acbc9 |
| Structured Product Labeling (SPL Set ID) | 16d49c45-5b0a-a7fa-e063-6294a90a7320 |
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