DOLUTEGRAVIR SODIUM Recall D-0896-2022
Description: Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
DOLUTEGRAVIR SODIUM Recall D-0896-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0896-2022 |
| Event ID | 90166 |
| Brand | TIVICAY |
| Generic Name | DOLUTEGRAVIR SODIUM |
| Manufacturer | DOLUTEGRAVIR SODIUM |
| Original Package? | 1 |
| Active Substance | DOLUTEGRAVIR SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S. |
| Quantity | 328 bottles |
| Recall Reason | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026. |
| Drug Classification | Class III |
| Drug Code Info | 20220601 |
| Product NDC | 49702-226 49702-255 49702-227 |
| Drug UPC | 0349702228139 0349702227132 0349702226135 |
| Recall Initiation Date | 20220513 |
| Report Date | 20220601 |
| Classification Date | 20220525 |
| Address | 1011 N Arendell Ave 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) | 8f3d58d9-e71b-4339-8139-4599d2957c9c |
| Structured Product Labeling (SPL Set ID) | 63df5af3-b8ac-4e76-9830-2dbb340af922 |
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