Exela Forced to Recall Three Separate Drugs Over Particulate Issues

In the last several years, rogue particles detected in drugs have triggered a multitude of recalls, the most recent of which affected pharmaceutical industry titans Pfizer and GSK. Now, the specialized pharmaceutical manufacturer Exela Pharma Sciences, situated in North Carolina, has been affected by the contamination.

The three different medications that Exela has been working with the FDA to recall are injectable sodium bicarbonate for metabolic acidosis, midazolam sodium chloride injection for sedation, and the nutrition additive Elcys, also known as cysteine hydrochloride. Checks of leftover specimens revealed silicone matter in certain vials, which led the company to proceed with the recall. 

According to the website of the firm, Exela is a specialized pharmaceutical company with a primary focus on the research, development, and production of sterile injectable pharmaceuticals, both generic and name brand, which have “high barriers to market entry.”  

According to Exela’s FDA notice, injecting medications that are contaminated with particles might cause discomfort or edema at the injection site. If the particulate matter makes its way into the blood vessels, it has the potential to move to other organs and obstruct the blood vessels in the heart, lungs, or even brain. This might potentially result in a stroke or even death.

As of Wednesday, Exela had not been notified of any potential adverse effects flagged in connection with the recall.

According to the FDA recall notice, Exela is voluntarily recalling eight lots of sodium bicarbonate that were packaged in single-dose vials of 50 milliliters. The medications were supposed to expire between November 2023 and December next year.

The recall also applies to a single batch of sodium bicarbonate injections sold under the Civica brand, which was supposed to be good until August 2024.

Regarding the other two medications that are subject to the recall, Exela is only withdrawing one lot of midazolam and one lot of Elcys. The expiration dates for these two medications were July 2024 and March 2025, respectively. Exela delivered the drugs between July end to early August. 

The discovery of foreign material in a batch of medication is a definite way to cause a recall, and even the most successful pharmaceutical companies aren’t immune to this problem.

The Hospira division of Pfizer initiated a voluntary recall of sodium bicarbonate and lidocaine HCI injectables at the start of October owing to the potential presence of glass fragments in the vials containing the medications.

Moreover, the Food and Drug Administration of Taiwan ordered the recall of two lots of the serious asthma injection Nucala manufactured by GSK in July after glass particles were discovered in a vial of the treatment.