Nephron recalls millions of pharmaceutical products over sterility concerns
Nephron Pharmaceuticals is recalling several product lines out of concerns that the items may not be properly sterilized.
The U.S. Food and Drug Administration lists the voluntary, firm-initiated recall of 20 separate product lines initiated May 18, covering more than 2 million individual items produced at Nephron’s Lexington County compounding center.
The recall list covers syringes pre-filled with different medications, distributed around the United States. Nephron told The State there is no indication the products were contaminated or threaten patient safety, and the recall is a precautionary measure. A statement to the newspaper did not indicate what issue had led to the recall.
“Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots,” Nephron CEO Lou Kennedy said in a statement. “We do not take this lightly. While there has been no impact to patient safety, and there is no evidence of contamination, Nephron has decided in the interest of patients to proceed with this recall process. The company is prepared to provide the resources and information necessary to health care providers and patients to make certain they have anything they need and any questions answered. They remain our top priority.”
A Nephron spokesman said the company is working to update its processes in its compounding operation, which “may result in changes or pauses to production schedules or outbound packaging” at its Lexington County center.
Nephron employs 4,000 full and part-time employees at a 715,000-square-foot campus in a Lexington County industrial park south of Cayce, which opened in 2015.
This story was originally published June 1, 2022 at 5:00 AM.
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