Lacerations aren’t typically the sort of side effect one associates with a faulty drug, but in Exela Pharma Sciences’ case, the threat has prompted a mass recall of an injectable used to treat a kidney disease complication.
Exela is yanking 49 lots of its sodium bicarbonate 8.4% from the U.S. market over safety concerns of “vial breakage and flying glass,” the company said in a notice on the FDA’s website. The threat arises when the injectable is pressurized prior to use, Exela explained.
As of the middle of the week, Exela said it had so far received five reports of flying glass that resulted in injuries to the skin, eye and other body parts.
“There have been no reports of sterility failures,” the company added in its recall announcement.
The medicine, which is sold under both Exela and Civica brands, is used to treat metabolic acidosis, which refers to the buildup of acid in the body through kidney disease or kidney failure.
The suspect lots cover both Civica and Exela versions of sodium bicarbonate injection, which comes in a 50-ml glass vial. Each carton included in the recalled contained 20 vials. Some lots of Exela’s injection were due to expire as early as October 2023, while other batches were meant to be good until March 2024.
The products being pulled from market were previously shipped out across the U.S. between Dec. 16, 2021, and Aug. 10, 2022.
The recall isn’t expected to result in any drug shortages, Exela added in its release.
While many recalls are spurred by problems like labeling mix-ups or contamination with particles or suspected carcinogens, drug-device malfunctions have also had their fair share of product pulls in recent months.
Back in March, Adamis Pharmaceuticals launched a voluntary recall of four lots of its epinephrine injection Symjepi over concerns clogs in needles could stop the medicine from dispensing properly.
That same month, Gilead Sciences received an FDA rejection on its application for long-acting HIV candidate lenacapavir tied to chemistry manufacturing and controls concerns over the compatibility of Gilead’s drug with the vials it was stored in. The FDA’s complete response letter followed a clinical hold on 10 lenacapavir studies tied to the risk that the borosilicate vials that contained the drug could interact with lenacapavir to create “subvisible” glass particles, Gilead said in December.
Gilead sprung lenacapavir from its clinical hold in May after switching to an alternative vial made of aluminosilicate glass.