Drug recall
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle…
FDA recall event 94634 · Class III · GlaxoSmithKline LLC
Key facts
| Event ID | 94634 |
|---|---|
| Recall numbers | D-0544-2024 |
| Recalling firm | GlaxoSmithKline LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | 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. |
| Initiation date | May 17, 2024 |
| Report date | Jun 12, 2024 |
| Termination date | Jan 29, 2025 |
| 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: