AuroMedics’ double take: Glass in vials prompts another recall in US

By Flora Southey contact

- Last updated on GMT

GettyImages/Esben_H
GettyImages/Esben_H
AuroMedics has recalled injectable products in the US for the second time in as many months after detecting glass particles in vials.

The recall refers to lot AFO l 17001-A of Ampicillin and Sulbactam for injection USP, 1.5 g, used to treat infections due to susceptible strains of microorganisms in the skin, intra-abdominal, and gynaecological injections.

AuroMedics – a wholly owned subsidiary of Hyderabad, India-based Aurobindo Pharma – said it shipped the products to wholesalers and/or hospitals on February 9 last year, and has not received any reports of adverse events related to this recall to date.

On December 19, 2017, the firm issued​ a voluntary recall after a piece of glass was found in a vial of its generic injectable product Pantaprazole Sodium, used for the short term treatment of gastroesophageal reflux disease.

In both instances, the US Food and Drug Administration (FDA) warned administrating 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,” ​the FDA added.

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

Other news

Aurobindo Pharma released the positive regulatory news last week​ that the FDA had approved its Fondaparinux Sodium injection single-dose prefilled syringes.

The drug is a generic version of Mylan’s Arixtra, indicated to prevent deep vein thrombosis (DVT).  

Related topics: Regulatory & Safety, Regulations

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