REMDESIVIR Recall D-0005-2025
Description: Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
REMDESIVIR Recall D-0005-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0005-2025 |
| Event ID | 95399 |
| Brand | VEKLURY |
| Generic Name | REMDESIVIR |
| Manufacturer | REMDESIVIR |
| Original Package? | 1 |
| Active Substance | REMDESIVIR |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the U.S.A. |
| Quantity | 105,000 vials |
| Recall Reason | Presence of Particulate Matter: Presence of glass particle. |
| Drug Classification | Class I |
| Drug Code Info | 20241009 |
| Product NDC | 61958-2901 61958-2902 |
| Product NUI | N0000193948 |
| Pharma Class (EPC) | SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor [EPC] |
| Recall Initiation Date | 20240919 |
| Report Date | 20241009 |
| Classification Date | 20241003 |
| Address | 333 Lakeside DrN/A Foster City, CA 94404-1147 United States |
| Recalling Firm | Gilead Sciences, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3QKI37EEHE |
| Drug Application Number | NDA214787 |
| Structured Product Labeling (SPL ID) | 2f376e87-3504-46e9-ad36-56556d90634b |
| Structured Product Labeling (SPL Set ID) | c0978fa8-53ff-4ca2-82a7-567fd3e958ca |
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