Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains...
FDA Recall #D-0544-2024 — Class III — May 17, 2024
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
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.
Recalling Firm
GlaxoSmithKline LLC — Zebulon, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
463 Cartons
Distribution
Nationwide within the United States
Code Information
Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated