WEST COLUMBIA, S.C. — The U.S. Department of Veterans Affairs (VA) has issued an internal recall and removed all products from Nephron Pharmaceuticals.
This comes after the agency said Nephron faced scrutiny from the U.S. Food and Drug Administration (FDA) for possible bacterial contamination of equipment and cross contamination of drugs.
In a statement to News19, the VA said it “has removed all Nephron products from use until the FDA feels that they have received sufficient response from the manufacturer to change the rating of this facility to acceptable for manufacturing and that use of these products is safe.”
All VA facilities were notified of the internal recall on Dec. 6, 2022 and asked to notify affected patients by December 20, 2022.
According to its website, Nephron supplies inhalation products, gloves, and pre-filled medications to requesting businesses. News19 reached out to Nephron for comment but did not hear back by publication.
The West Columbia-based company has faced scrutiny in the past. According to the FDA’s website, 61 recalls were issued last year for issues, including possible cross contamination and lack of assurance of sterility.
“The FDA’s highest priority is protecting public health and will take action, as appropriate, to ensure patients have access to quality-made drug products,” the FDA said in a statement to News19. “Beyond that, as a general policy, the FDA does not comment on ongoing compliance matters.”
As of December 29th, VA facilities reported 39,672 patients have been impacted.