Eugia, a unit of Aurobindo, has issued a voluntary recall for one lot of the injectable antibiotic vancomycin hydrochloride, citing the possible presence of glass particles in the vials.
The recalled product, which is typically used to treat septicemia, infective endocarditis, skin infections and lower respiratory tract infections, is packaged in 30ml, 10-vial packs with the lot number 3VM26026A and an expiration date of July 2028.
The product was distributed nationwide in the U.S. between Sept. 2 and Sept. 15 of this year.
The company warned in a letter posted to the FDA’s product safety website that use of the recalled lot could cause “blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death.”
As of the posting, dated Nov. 6, the company said it hadn’t received any reports of adverse effects related to the recall.
In August, Eugia’s facility in Hyderabad was hit with a warning letter that was related to an inspection earlier this year that resulted in a Form 483. Prior to that rebuke, the company had received four FDA Form 483s across various sites in its network since late 2023.
Meanwhile, multiple other drugmakers producing injectable medicines have struggled with particulate contamination issues this year, leading to recalls from the likes of Par Health, B. Braun and Baxter, to name a few examples.