SOUTH CAROLINA (WSPA) – A South Carolina drug manufacturer is at the center of a recall by the Department of Veterans Affairs.
The VA recall is for all drugs its patients use, that are made by Nephron Pharmaceuticals out of Lexington County.
This all stems from a prior Food and Drug Administration (FDA) investigation that found drug safety issues at the facility.
The VA said the recall affects nearly 40,000 of its patients, but doctors are advising the general public to check their own medicines to see if they might be affected.
Ever since Nephron Pharmaceuticals built its facility in Lexington County in 2010, it has been making generic inhalation and suspension drugs that treat a variety of health issues from respiratory conditions to pain.
In the Spring of 2022, the FDA found major issues during an inspection and issued this “warning letter” to Nephron, noting quote “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”
Dr. David Brancati at Emergency M.D. explained why patients want to take possible contamination seriously.
“When you get bacteria or fungus into the manufacturing process the concern is that it can propagate inside those files and then when you’re inhaling it, it could be at a much higher concentration, so it is important to preserve the sterility of medications that are going into the body,” Dr. Brancati said.
This week the VA recalled all Nephron products it uses like the inhaler Albuterol, the nasal spray Ipratropium, the IV solution Sodium Chloride and the steroid Budesonide.
In a statement, the VA explained the recall.
It said, “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…VA 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.”
In response, the company told 7NEWS in a statement, “First and foremost, Nephron takes any such correspondence from the VA or any agency seriously. Second, Nephron will work with the VA – in the same cooperative and collaborative manner it has worked with FDA – to resolve any outstanding matters or concerns the VA has. Our commitment to quality remains second to none because the lives of patients depend on the hard work of our team.”
Prior Nephron recall
Well before the VA recall, Nephron issued its own national recall of roughly 4 million doses of drugs that relieve pain, reduce bleeding and control blood pressure.
Most of those drugs were used in hospitals and clinics.
Just in the last two weeks, the FDA cited two new recalls that the agency says are still pending.
In reference to this year’s recalls, the company sent this statement: “Out of an abundance of caution, working together with FDA, Nephron has initiated voluntary recalls, narrow in scope, of Rocuronium Bromide for Injection – although the investigation concluded no impact for potential patients – and Racepinephrine inhalation solution for potential low fill volume. Nephron always puts the safety of patients as its highest priority.”
You can find a full list of Nephron’s recalled drugs on this FDA page.
What should you do?
If all these recalls have you concerned about the manufacturer, Dr. Brancati has this advice.
“Do not stop your medicine. Contact the pharmacy first and then contact your physicians because they can possibly get you another medicine, or the same medicine that is made by a different manufacturer.”
The FDA has designated Nephron Pharmaceuticals as “official action needed” which is the highest level of classification for issues that need to be resolved.
While the agency cannot comment on specifics, the FDA said it is working with the company to address the issue as the compliance matter is ongoing.
You can find a full list of Nephron products by pressing the “show products” plus sign in the “Respiratory Therapy” and “503B Outsourcing,” sections of this page.