Nephron Pharmaceuticals, a generic drug maker, cited sterility issues as the cause of a voluntary nationwide recall of 2.1 million doses of medicine.
The recall listed on the FDA’s website specifies “lack of assurance of sterility” as the trigger for the company’s action.
In a statement, Nephron CEO Lou Kennedy told WIS News there "has been no impact to patient safety, and there is no evidence of contamination" but that the company has recalled the products "in the interest of patients."
The Columbia, South Carolina-based company said it was cooperating with the FDA and will provide information to healthcare providers and patients.
Among the products being recalled are sodium bicarbonate injections, epinephrine injections, fentanyl citrate bags and many others.
Nephron, which moved to South Carolina in 2015, pumped $215.8 million into its facility in 2020 as it was experiencing explosive growth in its generic inhalation and suspension products.
The company is no stranger to recalls. In 2015, when the company was still based in Orlando, Florida, it recalled more than 80,000 cartons of its over-the-counter asthma treatment, which it said had discoloration issues. The company had previously raised the ire of the FDA in 2013 concerning approval and marketing issues regarding the OTC asthma product.