GlaxoSmithKline LLC recalls Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tabl…

Recall date

May 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0544-2024

FDA classification

Class III

Brand / firm

GlaxoSmithKline LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Tivicay PD (dolutegravir) 5mg 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, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37