GlaxoSmithKline LLC: Drug Recall

Recall #D-0896-2022 · 05/13/2022

Class III: Low Risk

Recall Details

Recall Number: D-0896-2022
Classification: Class III
Product Type: Drug
Recalling Firm: GlaxoSmithKline LLC
Status: Terminated
Date Initiated: 05/13/2022
Location: Zebulon, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 328 bottles

Reason for Recall

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.

Product Description

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

Distribution Pattern

Nationwide in the U.S.

Other Recalls by GlaxoSmithKline LLC

Class III: Low Risk 05/17/2024

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.
Class III: Low Risk 12/12/2023

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

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.