Safety Report: Veklury® (remdesivir 100 mg for injection) - recalled due to glass particulates, USA

United States

Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD) today announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates.

Risk Statement: The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead Sciences Inc. has not received any reports of adverse events related to this recall.

Veklury is indicated for the treatment of adults and pediatric patients ≥ 12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single dose clear glass vials in powder form and reconstituted at the site of use.

Veklury lots 2141001-1A and 2141002-1A were distributed nationwide in the United States, beginning October 2021. NDC, lot, expiration date and distribution dates can be found below.

Product Description: Veklury® (remdesivir 100mg for injection)
NDC: 61958-2901-02
Lot #: 2141001-1A - 2141002-1A
Expiration Date: 01/2024 - 01/2024
Distribution date to wholesalers: 10/25/21-10/26/2021 - 10/26/21-11/02/2021

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-two-lots-vekluryr-remdesivir-due-presence-glass

Source: FDA