Gilead Sciences' unexpected blockbuster Veklury bravely accepted its criticism of the efficacy. Now, the drug has encountered a manufacturing failure. 

After a customer complaint pointed out the presence of glass particles, Gilead is recalling two batches of the COVID-19 antiviral drug Veklury, also known as Remdesivir. The company said on Friday that Gilead confirmed the complaint through its own investigation. 

Veklury was one of the pioneers of COVID-19 treatment last year. It remains the first and only coronavirus drug to be fully approved by the FDA. Despite doubts about its efficacy, due to the spread of virus variants and the increase in hospitalization rates, this antiviral drug will re-populate in the second half of 2021.

Gilead said that as for the recall, injections of drugs containing glass particles may cause local irritation or swelling. However, according to the company, if the glass particles reach the blood vessels, it will spread to various organs and block the blood vessels in the heart, lungs and brain, which may cause stroke or even death.

As of Friday, Gilead said it has not received any reports of side effects related to the recall.

The two affected batches were shipped nationwide in October and November, respectively. These batches were originally scheduled to expire in January 2024. 

Related: As Veklury's sales decline, Gilead hopes to rebound faster from Biktarvy and other HIV drugs

Gilead did not specify where the batches were produced or who produced them. The company did not immediately respond to Fierce Pharma's request for comment. 

As one of the earliest COVID-19 drugs, Veklury's data profile has been placed under a microscope. In October last year, the World Health Organization announced the results of its 11,200-person solidarity trial, which took a hit. The trial found that Veklury “seems to have little or no impact on hospitalization with COVID-19” length of stay and overall mortality. 

In a follow-up study called NOR-Solidarity, Veklury and hydroxychloroquine failed to significantly clear the virus from hospitalized patients or affect the degree of respiratory failure and inflammation after 10 days. 

At the same time, the results of the European Discovery trial published in September showed that patients who used Veklury did not perform better than patients who received standard treatment alone. 

Nevertheless, with the spread of the variant, the popularity of Veklury has recovered in recent months. The drug brought in revenue of $1.9 billion in the third quarter, far higher than Zacks' $502 million in the same period. In 2020, Veklury generated $2.8 billion in revenue.

Related: With the launch of the vaccine, Gilead cancelled the Veklury COVID-19 trial and provided more convenient drugs for outpatients

In terms of manufacturing, particulate pollution has also caused trouble for other companies this year. Fresenius Kabi (Fresenius Kabi) extracted a batch of anti-inflammatory drug ketorolac tromethamine injection in January after particles appeared in the stock samples. 

Generic drug giant Teva Pharmaceutical withdrew a batch of cancer drug topotecan injection after complaining in a pharmacy in July that there was a single glass particle in a bottle of the drug. A follow-up review of the sample found two other particles, which were identified as gray silica gel and "translucent colorless cotton fibers."

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