Exela Issues Recall Over Risk of Flying Glass
Exela Pharma Sciences is recalling 49 lots of sodium bicarbonate injection used to treat metabolic acidosis resulting from kidney failure, because of the risk of vial breakage and flying glass when being pressurized for administration.
These lots were distributed nationwide to wholesalers, distributors and other customers between Dec. 16, 2021 and Aug. 10. The affected lots were distributed in 20-count cartons only and the recall is not expected to lead to a drug shortage.
The company said it has received five reports of flying glass injuring the skin, eye and other body parts. There have been no reports of sterility failures so far, Exela said.