FDA-Drug2022-06-01Class III

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

GlaxoSmithKline LLC
Hazard

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.

Sold states
Nationwide in the U.S.
Affected count
328 bottles
Manufactured in
1011 N Arendell Ave, Zebulon, NC, United States
Products
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0896-2022

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