Recall of COVID treatment after glass found in drug

In light of the increasing number of COVID-19 cases in the United States, pharmaceutical company Gilead Sciences, Inc., in collaboration with the U.S. Food & Drug Administration (FDA), has announced a voluntary recall of its antiviral drug Veklury, commonly known as Remdesivir.

The recall came after glass particles were discovered in the drug's vials, raising concerns about patient safety at a time when the drug's importance in treating severe COVID-19 cases is being re-emphasized.

The affected batch, designated 47035CFA, was distributed nationwide in the United States beginning July 16, 2024. This FDA-monitored recall coincides with data from the U.S. Centers for Disease Control and Prevention (CDC) showing high levels of COVID-19 virus activity in wastewater across the country, despite a recent decline in the number of positive cases.

On September 13, the CDC reported that while overall viral activity in wastewater was downgraded from “very high” to “high,” 21 states still have “very high” levels, particularly in the West. Sixteen states have “high” levels, eight are classified as “moderate,” and only Michigan and Rhode Island have “low” levels. New York stands out with “minimal” levels, the lowest rating.

The recall of Veklury comes at a critical time in the pandemic. Although positive tests now account for 14.9 percent of all Covid tests in the US (excluding home tests), 1.6 percent less than the previous week, the emergence of new subvariants is keeping health authorities on high alert.

According to Gilead's risk statement, administration of Veklury, which contains glass particles, could lead to a range of complications, from local irritation to potentially life-threatening situations if the particles enter the bloodstream and cause blockages in vital organs.

Veklury has been an important tool for treating COVID-19 since its FDA approval in October 2020. It is intended for use in both hospitalized patients and patients with mild to moderate COVID-19 who are at high risk of disease progression.

The recall affects the freeze-dried form of Veklury in single-dose clear glass vials containing 100 mg of remdesivir in powder form. Gilead has not reported any adverse events related to this recall to date, but is taking proactive measures to minimize risks.

This recall also comes as the U.S. grapples with a new class of COVID-19 subvariants nicknamed FLiRT. As of August 31, the dominant subvariant KP.3.1.1 was responsible for more than 50 percent of all U.S. COVID-19 cases over the past two weeks, with FLiRT variants overall responsible for over 80 percent of cases.

While these new variants appear to be more contagious, they generally do not cause symptoms as severe. However, the CDC continues to monitor common symptoms such as fever, cough, shortness of breath, fatigue, and loss of taste or smell.

Healthcare facilities that have the recalled Veklury are urged to stop using it immediately and return the product. Gilead has set up a special information line at 1-866-633-4474 for those who want to know details about the recall.

Patients who have concerns about their COVID-19 treatment are advised to consult their healthcare provider. Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program.