VOLUNTARY WHOLESALER/DISTRIBUTOR AND RETAIL-LEVEL RECALL IN THE US OF ONE LOT OF TIVICAY (DOLUTEGRAVIR) 50 MG TABLETS DUE TO INCORRECT EXPIRY DATE
ViiV Healthcare has initiated a voluntary wholesaler/distributor and retail-level recall in the US of lot 2A9E of Tivicay 50 mg Tablets with an incorrect expiry date of January 2027. The correct expiry date should be September 2026.
A small number (328 bottles) of Tivicay 50 mg Tablets from lot 2A9E with the incorrect expiry date have been shipped to a wholesaler/distributor and most of those units subsequently have been shipped to retail pharmacies. It is possible that some patients may have received one of the mislabeled bottles.
Because the product released to the market is currently well within the actual expiry date, there is no immediate impact to patient safety. Patients should use the product before September 2026 and take as instructed by their healthcare professional.
The recall will not have an impact on the supply of Tivicay 50 mg Tablets anywhere in the world.
No other products, and no other strengths of Tivicay, are impacted by this recall.
Wholesalers, distributors and retail pharmacies that have questions about the recall process for Tivicay 50 mg Tablets, lot 2A9E, should contact Sedgwick, ViiV Healthcare/GSK’s vendor for recall services, at 1-888-667-1461.
People living with HIV who have received a bottle of Tivicay 50mg Tablets from lot 2A9E and have questions should contact ViiV Healthcare’s Response Center at 1-877-844-1461.
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