Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

FDA recall notice · announced June 1, 2022 · Glaxosmithkline

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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 is September 2026.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot: 2A9E, Exp 1/2027
Quantity: 328 bottles
Status: Terminated
Products in this recall event:
- Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. (D-0896-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.