GlaxoSmithKline LLC recalls Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49…

Recall date

May 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0896-2022

FDA classification

Class III

Brand / firm

GlaxoSmithKline LLC

Sold / distributed

Nationwide in the U.S.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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