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 company’s website.
Injecting 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 flags linked to the recall.
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.
The recall also covers a single lot of Civica-branded sodium bicarbonate injection that was meant to be good until August of next year.
As for the other two drugs in the recall, Exela is pulling just a single 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.
Bits of 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 Drug Administration in July initiated a recall of two batches of GSK’s severe asthma injection Nucala after glass particles were found in a vial of the drug.