Recalls / Class III
Class IIID-0544-2024
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
- Brand name
- Tivicay
- Generic name
- Dolutegravir Sodium
- Active ingredient
- Dolutegravir Sodium
- Route
- Oral
- NDCs
- 49702-226, 49702-255, 49702-227, 49702-228
- FDA application
- NDA204790
- Affected lot / code info
- Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
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.
Recalling firm
- Firm
- GlaxoSmithKline LLC
- Manufacturer
- ViiV Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 N Arendell Ave, N/A, Zebulon, North Carolina 27597-2309
Distribution
- Quantity
- 463 Cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-17
- FDA classified
- 2024-06-06
- Posted by FDA
- 2024-06-12
- Terminated
- 2025-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0544-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.