Drug recall D-0896-2022
Product
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Reason for recall
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.
Lots and codes
Lot: 2A9E, Exp 1/2027
Recall details
- Recalling firm
- GlaxoSmithKline LLC, Zebulon, NC
- Quantity
- 328 bottles
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 13, 2022
- Terminated
- August 17, 2023
Related products
- Tivicay – drug information
- NDC 49702-255 Tivicay PD · Dolutegravir Sodium 5 mg/1 · ViiV Healthcare Company
- NDC 49702-227 Tivicay · Dolutegravir Sodium 25 mg/1 · ViiV Healthcare Company
- NDC 49702-228 Tivicay · Dolutegravir Sodium 50 mg/1 · ViiV Healthcare Company
- NDC 49702-226 Tivicay · Dolutegravir Sodium 10 mg/1 · ViiV Healthcare Company