AuroMedics Pharma LLC has recalled certain vials of pantoprazole sodium I.V. over concerns that the vials may contain glass particles.
Pantoprazole Sodium is the generic version of Protonix, a proton pump inhibitor that has been named in lawsuits over its alleged potential to cause kidney failure and other serious renal complications.
According to a recall notice posted by the U.S. Food & Drug Administration (FDA) on December 19th, AuroMedics Pharma received one complaint regarding glass particles in a single vial of pantoprazole sodium I.V.
The recall affects one lot of pantoprazole sodium for injection, 40 mg per vial, distributed in cartons containing 10 vials. The affected vials have an NDC number of 55150-202-10. The lot number is CPO170035, with an expiration date of May 2019. The were distributed on August 7, 2017.
“The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening,” the recall notice stated.
So far, no adverse events have been linked to the recalled lot.
AuroMedics Pharma LLC is notifying its customers of the recall. Consumers and distributors who have any recalled vials in their possession have been advised to stop using it immediately and return the vial to the place of purchase and contact their doctor as appropriate.
Consumers with questions regarding this recall can contact Aurobindo Customer Service weekdays 9:00AM to 5:00PM EST at 866-850-2876 Option 1.
In 2013, more than 15 million Americans used Protonix or another prescription proton pump inhibitors to treat symptoms associated with the excess production of stomach acid. However, an increasing number of studies have suggested that long-term treatment with proton pump inhibitors may harm the kidneys, leading to kidney failure, chronic kidney disease, acute kidney injury, and acute interstitial nephritis.
More than 360 proton pump inhibitor lawsuits have been centralized in a multidistrict litigation currently underway in New Jersey federal court, all of which were filed on behalf of individuals who developed kidney failure and other kidney side effects allegedly related to treatment with Nexium, Prilosec, PrevAcid, Dexilant, and Protonix.
Among other things, plaintiffs claim that the drugs’ manufacturers have long known of evidence linking their products to serious kidney complications, yet failed to provide doctors and patients with adequate warning of these risks. They further assert that they could have avoided these kidney side effects had they received proper notice of the drug’s side effects.
In addition to kidney problems, recent studies have linked long-term proton pump inhibitor use to a range of serious side effects, including heart attacks, bone fractures, low magnesium levels, and stomach cancer.