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

By Flora Southey contact

- Last updated on GMT

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: Markets & Regulations, Regulations

Related news

Show more

Related products

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more