Drug recall D-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
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.
Lots and codes
Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Recall details
- Recalling firm
- GlaxoSmithKline LLC, Zebulon, NC
- Quantity
- 463 Cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 17, 2024
- Terminated
- January 29, 2025
Related products
- Tivicay – drug information
- NDC 49702-255 Tivicay PD · Dolutegravir Sodium 5 mg/1 · ViiV Healthcare Company
- NDC 49702-227 Tivicay · Dolutegravir Sodium 25 mg/1 · ViiV Healthcare Company
- NDC 49702-228 Tivicay · Dolutegravir Sodium 50 mg/1 · ViiV Healthcare Company
- NDC 49702-226 Tivicay · Dolutegravir Sodium 10 mg/1 · ViiV Healthcare Company