AuroMedics Pharma LLC Recalls Pantoprazole Sodium for Injection

News
Article

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

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

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.