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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

GlaxoSmithKline LLC 2024-06-12 Health moderate FDA
Health · FDA · Recall #FDA-D-0544-2024

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton… Recall

Issued June 12, 2024 · GlaxoSmithKline LLC

In June 2024, GlaxoSmithKline LLC recalled the Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact GlaxoSmithKline LLC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
GlaxoSmithKline LLC
Category
Health
Recall date
June 12, 2024
Units affected
Not reported
Sold at
Nationwide within the United States
Recall number
FDA-D-0544-2024
Made in
United States
Issuing agency
FDA

In context

  • GlaxoSmithKline LLC has 3 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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