预约演示

Specialty injectables maker Exela issues recall after particles turn up in 3 different drugs

2023-10-27

Exela Pharma Sciences, based in Lenoir, North Carolina, is a specialty pharmaceutical company focused on developing and manufacturing generic and name-brand sterile injectable products with “high barriers to market entry."

Exela Pharma Sciencesng up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. Now, North Carolina-based specialty drugmaker Exela Pharma Sciences has taken the contamination hit.

Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate for metabolic acidosis; midPfizer sodiGSKchloride injection for sedation; and the nutritiExela Pharma Sciencesso known as cysteine hydrochloride—after inspections of leftover samples flagged silicone matter in some vials.

Exela, based in Lenoir, NoFDA Carolina, is a specialty pharmaceuticinjectable sodium bicarbonateing ametabolic acidosisenmidazolam sodium chloridele injectable products with “high barriers to marketElcysy,” according tocysteine hydrochloride.

Exelating drugs contaminated with particulates can cause injection site irritation or swelling, Exela warned in an FDA notice. If the particulate matter reaches the blood vessels, it could travel to various organs and block blood vessels in the heart, lungs or brain, the company added. That could cause stroke or even death.

As of Wednesday, Exela had not received any side effect finjection site irritation.swelling Exela FDA stroke

Exela is recalling eight batches of sodium bicarbonate that contain 50-ml single-dose vials, according to the FDA recall notice. The drugs were set to expire between November 2023 and December 2024.

Exelaecall also covers a single lot sodium bicarbonatesodium bicarbonate injection that was meant to be good uFDAl August of next year.

As for the other two drugs in the recall, Exela is pulsodium bicarbonate lot each of midazolam and Elcys, which were set to expire in July 2024 and March 2025, respectively.

Exela shipped out the medications between late July and early August.midazolam Elcys

Exelaof matter cropping up in drug batches is a surefire way to trigger a recall, and even pharma juggernauts aren’t immune.

At the beginning of October, Pfizer’s Hospira unit issued a voluntary recall of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in the vials.

Meanwhile, Taiwan’s Food and PfizerdmiHospiraion in July initiated a recall of tsodium bicarbonates severe asthma injection Nucala after glass particles were found in a vial of the drug.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构