Drug recall
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC…
FDA recall event 90166 · Class III · GlaxoSmithKline LLC
Key facts
| Event ID | 90166 |
|---|---|
| Recall numbers | D-0896-2022 |
| Recalling firm | GlaxoSmithKline LLC |
| Product type | Drugs |
| Products | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | 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… |
| Initiation date | May 13, 2022 |
| Report date | Jun 1, 2022 |
| Termination date | Aug 17, 2023 |
| City | Zebulon |
| State | NC |
| Country | United States |
| FEI number | 1033964 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: