The company said there have been iron oxide particulates found in a vial.
After a complaint about small, dark particulate matter found in a vial of Oxacillin, Sagent Pharmaceuticals issued a voluntary recall for a lot of the drug distributed in June and July this year.
Oxacillin for Injection is an antibiotic that can fight bacteria, such as staphylococci and is administered intravenously. It is in the penicillin class of drugs.
The company identified the particulates as iron oxide, and cautions that if it is injected, it may cause adverse events in the patient. They state that swelling, irritation of blood vessels or tissue, or blockage of blood vessels may occur, according to a press release.
A serious, life-threatening event can occur as a result of a blocked blood vessels, such as stroke, heart attack, respiratory, kidney, or liver failure. However, the company did not indicate that any patients have reported adverse events yet.
Sagent recommends that patients discontinue the use of the drug from the specified lot and return the product.
They also urge patients who have experienced an adverse event as a result of the product to report it to the FDA’s MedWatch Adverse Event Reporting program, Sagent concluded.