HIV Medication Recalled

GlaxoSmithKline LLC is recalling 463 cartons of Tivicay PD because the product box lists incorrect expiration information. According to the June 12, 2024, US Food and Drug Administration (FDA) Enforcement Report, the drug expiration on the carton is an incorrect “2026-MAY” instead of the correct expiration date, “2025-APR,” which is on the tablet bottle label.

The recall affects Tivicay PD (dolutegravir) 5 mg tablets for oral suspension, 60-count bottles. Each carton contains one bottle of 60 tablets, one 30-mL dosing cup, and one 10-mL oral dosing syringe (NDC 49702-255-37), from lot AG4M (Exp. 5/26 is listed on the carton instead of correct 4/25). The product was manufactured for ViiV Healthcare, Durham, North Carolina, by GlaxoSmithKline, Durham, North Carolina, and was distributed within the United States.

GlaxoSmithKline voluntarily initiated the recall on May 17, 2024. On June 6, 2024, the FDA designated it Class III, suggesting use of the recalled medication is not likely to cause harm.

Tivicay PD is a prescription medication used to treat patients with HIV-1 infection.