AuroMedics Pharma LLC is recalling one lot of the injectable heartburn drug pantopazole sodium, a generic version of Protonix, because glass particles were seen floating in a vial from one batch. If injected, a product containing glass particles could cause adverse events including local irritation or swelling, or blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma has not received any adverse event reports or safety concerns related to this recall.
The recall involves pantoprazole sodium for injection 40mg per vial. The medication is used for the short-term gastroesophaeal reflux disease (GERD) associated with history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome and is packaged a carton containing 10 vials, NDC: 55150-202-10. The affected lot is CPO170035, ESP. May 2019.
It can be identified as “vial stoppered with grey slotted rubber stopper and sealed with aluminum seals having Sky Blue color polypropylene disc,” according to the company. Affected vials were shipped to customers on Aug. 7, 2017 and distributed to wholesalers and/or hospitals nationwide.
AuroMedics Pharma is notifying its distributors and customers and informing them to immediately stop using the recalled product and return it to the place of purchase. Patients should contact their doctor if they experience any adverse effects.
Any adverse events should also be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice