# FDA recall D-0544-2024

> **GlaxoSmithKline LLC** · Class III · drug recall initiated 2024-05-17.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0544-2024
- **Recalling firm:** GlaxoSmithKline LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-17
- **Report date:** 2024-06-12
- **Termination date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zebulon, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2024

## Citation

> AI Analytics. FDA recall D-0544-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0544-2024. Source: US FDA. Licensed CC0.

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