GlaxoSmithKline LLC: Drug Recall

Recall #D-0544-2024 · 05/17/2024

Class III: Low Risk

Recall Details

Recall Number: D-0544-2024
Classification: Class III
Product Type: Drug
Recalling Firm: GlaxoSmithKline LLC
Status: Terminated
Date Initiated: 05/17/2024
Location: Zebulon, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 463 Cartons

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.

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

Distribution Pattern

Nationwide within the United States

Other Recalls by GlaxoSmithKline LLC

Class III: Low Risk 12/12/2023

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class III: Low Risk 05/13/2022

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

View all recalls by GlaxoSmithKline LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.