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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0544-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 17, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- 463 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline LLC
Original FDA data
Every field from FDA enforcement report D-0544-2024, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 94634
- Address
- 1011 N Arendell Ave
- Code information
- Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
- Postal code
- 27597-2309
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0544-2024
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline LLC
- Product quantity
- 463 Cartons
- Termination date
- Jan 29, 2025
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2024