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Voluntary recall on Nephron products in place due to issues with sterility

The US Food and Drug Administration lists 20 products from the West Columbia facility that "lack assurance of sterility"

WEST COLUMBIA, S.C. — West Columbia-based Nephron Pharmaceuticals is conducting a voluntary recall of twenty products -- totaling in the hundreds of thousands of doses -- of pre-filled syringes and bags due to what the Food and Drug Administration (FDA) cites as a "lack of assurance of sterility."

Some of the pre-filled syringes contain doses of Epinephrine (used to treat life-threatening allergic reactions), Lidocaine (used to cause numbness for surgical patients), Glycopyrrolate (used to treat peptic ulcers in adults), Fentanyl Citrate (for treating severe cancer pain and as a surgical anesthesia) and Ketamine Hydrochloride (a sedative for diagnostic and surgical procedures). A complete list of products can be found here.

In a statement to the media, Lou Kennedy, Nephron Pharmaceuticals Corporation CEO and owner said, “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. 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.”

The company also stated that the 503B compounding station, which produces the pre-filled items remains open.

"As part of the continuing process to complete a recent and routine FDA inspection, and ensure Nephron has provided the agency with everything they need in response, there have been ongoing updates to processes around the facility. Some of these ongoing updates may result in changes or pauses to production schedules or outbound packaging in 503B. The company is in constant contact with hospitals and customers with any questions."

There has not been a danger to patient safety or contamination of the products that are being voluntarily recalled.

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