AuroMedics Pharma LLC Recalls Pantoprazole Sodium for Injection

On Dec. 19, 2017, AuroMedics Pharma LLC (East Windsor, NJ) announced it was voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The recall is in response to a product complaint of glass particles found in a vial.

The affected lot, CPO170035, is packaged in a carton containing 10 vials, NDC: 55150-202-10, and has an expiration date of May 2019. It was shipped to customers on Aug. 7, 2017. The recalled product is a vial stoppered with a grey slotted rubber stopper and sealed with aluminum seals with a sky blue polypropylene disc.

According to the company, “Pantoprazole Sodium for Injection 40 mg per vial is used for short-term treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome.” If product containing glass is intravenously administered, it may cause local irritation and swelling or, in more serious cases, cause blockage and clotting of blood vessels.

As of the date of the recall, the company has not received any adverse event reports. Adverse events can be reported to FDA’s MedWatch Adverse Event Reporting program.

Source: FDA