Rogue particles turning 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; midazolam sodium chloride injection for sedation; and the nutrition additive Elcys, also known as cysteine hydrochloride—after inspections of leftover samples flagged silicone matter in some vials.
Exela, 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,” according to the companyInjecting 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.
