FDA Drug recall 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 dosin…
- FDA Drug
- Class III
- terminated
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class III recall of Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosin… by Glaxosmithkline, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0544-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-05-17 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
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
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.
Identifiers
| ndc | 49702-255-37 |
|---|---|
| ndc | 49702-226-13 |
| ndc | 49702-227-13 |
| ndc | 49702-228-13 |
| code_info | Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0544-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.