FDAFDA · Food and drugs·Recall number D-0544-2024
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
Published June 12, 2024 · Recall initiated: May 17, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIVICAY
- Manufacturer
- GlaxoSmithKline LLC
- Distributor
- Nationwide within the United States
- UPC
- 0349702227132
- Lot
- Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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