Drug product
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
D-0544-2024
Product summary
- Event
- Event 94634
- Status
- Terminated
- Classification
- Class III
- Quantity
- 463 Cartons
- Official record key
drug-enforcement:D-0544-2024
Official wording
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.
Code information: Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect