Gilead recalls vials of its Remdesivir covid drug in U.S. due to glass contamination

·2 min read
Remdesivir bottles with syringe for treatment of covid-19

American biopharmaceutical company Gilead Sciences Inc. has issued a nationwide recall of two lots of its coronavirus treatment drug Remdesivir due to the "presence of glass particulates," the company said Friday.

Remdesivir, known also by its brand name "Veklury," is normally used for adults and children over 12 requiring hospitalization for covid-19, and is normally given in a vein by intravenous (IV) infusion one time each day for up to 10 days.

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"Gilead Sciences Inc. received a customer complaint, confirmed by the firm's investigation, of the presence of glass particulates," it said in a statement.

"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," it added.

But Gilead noted to date it had not yet "received any reports of adverse events related to this recall."

The California-based company did not immediately respond to a request for comment from The Washington Post late on Friday, but company spokesman Chris Ridley told Bloomberg the recall involved some 55,000 vials of the drug, enough to treat 11,000 hospitalized patients.

The drug is normally "distributed in single dose clear glass vials in powder form and reconstituted at the site of use," the company said. The vials being recalled were distributed nationwide in the United States, beginning October 2021.

Remdesivir gained emergency use authorization from the Food and Drug Administration in May 2020 with the United States buying up much of its global supply. It was also administered to former president Donald Trump when he was sick with covid-19. In October 2020 the antiviral drug became the first treatment for covid-19 to receive full FDA approval.

The FDA has outlined its use for adult patients, and pediatric patients 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and has said it should only be administered in a hospital or health care setting.

In its own study last year, Gilead said its drug led to an "improvement in clinical recovery" from covid-19 and a 62 percent reduction in risk of death when compared with patients receiving standard medical care, but said more clinical trials were needed.

Amid the new omicron coronavirus variant, the company said this week it expected Remdesivir to "continue to be active" against the new variant and that it would be conducting laboratory testing to confirm that analysis.

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The Washington Post's Amy Cheng contributed to this report.

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