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.
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).