May 2024 FDA Recall Tivicay by Glaxosmithkline Llc
D-0544-2024 - Labeling

This Class III drug recall was voluntarily initiated by Glaxosmithkline Llc on May 17, 2024 for the product Tivicay. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0544-2024

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.
Initiated
05-17-2024
Reported
06-12-2024
Quantity
463 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94634
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithKline LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025

Affected Packages Involved in this Recall

49702-255-37 Tivicay Pd
49702-226-13 Tivicay
49702-227-13 Tivicay
49702-228-13 Tivicay