VA recalls all Nephron products, warns veterans about SC manufacturer’s drugs
Veterans are being advised to stop using drugs produced by Lexington County-based Nephron Pharmaceuticals, according to the U.S. Department of Veterans Affairs.
All VA facilities were notified of the recall on Dec. 6, a VA spokesperson confirmed to The State, and notifications were sent to veterans taking Nephron products to stop using the manufacturer’s drugs.
The VA estimates 39,672 patients are affected by the recall.
Federal officials initiated the recall after the Food and Drug Administration warned of sterility concerns over products manufactured at Nephron’s expansive facility south of Cayce.
“There were multiple violations of good manufacturing practices found during the inspection, including bacterial contamination on some equipment and cross contamination of drugs across products,” a VA spokesman said in a statement.
TV station WRAL of Raleigh, N.C., was the first to report on the recall.
“First and foremost, Nephron takes any such correspondence from the VA or any agency very seriously,” Nephron said in its own statement in response to the recall. “Second, Nephron will work with the VA — in the same cooperative and collaborative manner it has worked with FDA this year — to resolve any outstanding matters or concerns the VA has. Our commitment to qualify remains second to none because the lives of patients depend on the hard work of our team.”
Last year, FDA inspectors dinged the drugs manufacturer for procedural deficiencies at the Lexington County facility that inspectors fear could have compromised the company’s drugs. Inspectors conducted a lengthy on-site inspection between March 28 and April 20, 2022.
In its report, the FDA criticized the number of “excursions” by outside organisms found in Nephron’s processing facilities, where high levels of cleanliness are necessary. The agency noted more than 1,600 such incidents were recorded in 2021 and the first quarter of 2022.
Nephron told The State at the time there was no indication the products were contaminated or threatened patient safety, and the recall is a precautionary measure. But the company did initiate a voluntary recall of more than 2 million products last spring “out of an abundance of caution.”
At the time, Nephron recalled 20 separate product lines, including syringes pre-filled with different medications.
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.
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