FDAFDA · Food and drugs·Recall number D-0896-2022
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Published June 1, 2022 · Recall initiated: May 13, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIVICAY
- Manufacturer
- GlaxoSmithKline LLC
- Distributor
- Nationwide in the U.S.
- UPC
- 0349702227132
- Lot
- Lot: 2A9E, Exp 1/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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