Exela Pharma Sciences is pulling three medications, including one Civica brand, because silicone was found in samples during routine inspection, the FDA said Oct. 25.
The three drugs are 8.4% sodium bicarbonate injection, 50 milliequivalent/50 milliliter vials, which treat metabolic acidosis; midazolam in 0.8% sodium chloride injection, 100 milligram/100 milliliter vials, a sedation therapy; and ELCYS (cysteine hydrochloride injection), 500 milligram/10 milliliter vials, which is total parenteral nutrition.
Use of an injectable drug with a particulate matter such as silicone can cause irritation, swelling and potentially death if the matter blocks blood vessels in the heart, lungs or brain. Exela has not received any adverse event reports related to the recall.
Ten of the 11 lots are Exela brands, and the Civica brand is one lot of 8.4% sodium bicarbonate injection, 50 milliequivalent/50 milliliter vials.
The drugs were sent to wholesalers, distributors and health systems between January 2022 and Sept. 26. Exela is notifying its customers to stop using the drugs and return remaining supply.