Recalls / Class III
Class IIID-0896-2022
Product
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
- Brand name
- Tivicay
- Generic name
- Dolutegravir Sodium
- Active ingredient
- Dolutegravir Sodium
- Route
- Oral
- NDCs
- 49702-226, 49702-255, 49702-227, 49702-228
- FDA application
- NDA204790
- Affected lot / code info
- Lot: 2A9E, Exp 1/2027
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.
Recalling firm
- Firm
- GlaxoSmithKline LLC
- Manufacturer
- ViiV Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 N Arendell Ave, Zebulon, North Carolina 27597-2309
Distribution
- Quantity
- 328 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2022-05-13
- FDA classified
- 2022-05-25
- Posted by FDA
- 2022-06-01
- Terminated
- 2023-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0896-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.