Class IIITerminated

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recall

FDA recall D-0544-2024 · initiated May 17, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

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.

Details

Product: 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
Recalling company: Glaxosmithkline LLC
Classification: Class III
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: May 17, 2024
FDA report date: Jun 12, 2024

This recall is linked to a product we cover: Tivicay →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0544-2024 ↗

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