D-0544-2024 Class III Terminated
FDA drug recall D-0544-2024 was initiated by GlaxoSmithKline LLC on May 17, 2024 and is designated Class III. 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. The recall status is terminated (terminated Jan 29, 2025). Affected quantity: 463 Cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 12, 2024
- Initiation Date
- May 17, 2024
- Termination Date
- Jan 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 463 Cartons
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
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.
Distribution pattern
Nationwide within the United States
Code information
Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0544-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026