Glass in AuroMedics injectables vial prompts US 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.”
