Drug product
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
D-0896-2022
Product summary
- Event
- Event 90166
- Status
- Terminated
- Classification
- Class III
- Quantity
- 328 bottles
- Official record key
drug-enforcement:D-0896-2022
Official wording
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.
Code information: Lot: 2A9E, Exp 1/2027
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Labeling or packaging
Labeling: incorrect or missing