GlaxoSmithKline LLC 2022-06-01 Health moderate FDA
Health · FDA · Recall #FDA-D-0896-2022
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV… Recall
Issued June 1, 2022 · GlaxoSmithKline LLC
In June 2022, GlaxoSmithKline LLC recalled the Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GlaxoSmithKline LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GlaxoSmithKline LLC
- Category
- Health
- Recall date
- June 1, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the U.S.
- Recall number
- FDA-D-0896-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- GlaxoSmithKline LLC has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.