DOLUTEGRAVIR SODIUM Recall D-0544-2024
Description: Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37
DOLUTEGRAVIR SODIUM Recall D-0544-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0544-2024 |
| Event ID | 94634 |
| Brand | TIVICAY |
| Generic Name | DOLUTEGRAVIR SODIUM |
| Manufacturer | DOLUTEGRAVIR SODIUM |
| Original Package? | 1 |
| Active Substance | DOLUTEGRAVIR SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 463 Cartons |
| Recall Reason | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR. |
| Drug Classification | Class III |
| Drug Code Info | 20240612 |
| Product NDC | 49702-226 49702-255 49702-227 |
| Drug UPC | 0349702227132 0349702226135 0349702228139 |
| Recall Initiation Date | 20240517 |
| Report Date | 20240612 |
| Classification Date | 20240606 |
| Address | 1011 N Arendell AveN/A Zebulon, NC 27597-2309 United States |
| Recalling Firm | GlaxoSmithKline LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1Q1V9V5WYQ |
| Drug Application Number | NDA204790 |
| Structured Product Labeling (SPL ID) | 57074f26-b92a-411a-a2e3-f0c9658e2669 |
| Structured Product Labeling (SPL Set ID) | 63df5af3-b8ac-4e76-9830-2dbb340af922 |
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