Glass in AuroMedics injectables vial prompts US recall

By Flora Southey contact

- Last updated on GMT

GettyImages/NikiLitov
GettyImages/NikiLitov

Related tags: Pharmaceutical drug

A piece of glass found in a vial of generic injectable product Pantoprazole Sodium has prompted AuroMedics Pharma to issue a nationwide voluntary recall.

The complaint concerns Pantaprazole Sodium for injection 40gm per vial lot CPO170035 – first shipped to US hospitals and/or wholesalers on August 7, 2017 – used for the short term treatment of gastroesophageal reflux disease.

The treatment also has a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome.

The US Food and Drug Administration (FDA) said the administration of a glass particulate in an intravenous drug could result in local irritation or swelling.

“More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening,” ​said the Agency.

To date, AuroMedics Pharma has not received reports of any adverse events related to this recall.

The firm did not respond to a request for comment before the time of publication.

AuroMedics Pharma is the wholly owned subsidiary of Hyderabad, India-based Aurobindo Pharma.

Earlier this week​, an Economic Times story​ suggested Aurobindo Pharma was one of seven companies interested in acquiring Orchid Pharma. Aurobindo denied​ the rumours, describing the report as “factually incorrect.”

Related topics: Regulatory & Safety, Regulations

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