Lake Forest, Ill.-based pharmaceutical company Hospira issued a voluntary recall of its injectable vancomycin hydrochloride due to the detection of particulate matter in a single vial, according to a Tuesday announcement from the Food and Drug Administration.
The product was distributed in the United States from August 2016 through September 2016.
"Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately," said the FDA in the release. "Inform healthcare professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you."
Previous research has classified the formation of particulate matter as one of the major quality concerns in the development of biopharmaceutical products. The possible presence of such particles in the Hospira antibiotic could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and low-level allergic reactions if injected.
Vancomycin hydrochloride is an antibiotic used to treat multiple conditions including serious infections caused by methicillin-resistant staphylococci. No adverse events involving the Hospira antibiotic have been reported.
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