LANSING, Mich. – (BUSINESS WIRE) – Neogen Corporation (NASDAQ: NEOG) is voluntarily recalling all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level. Neogen distributes this product, which is manufactured by a third-party supplier. This recall has been initiated due to microbial contamination in certain lots of 10 mL/50 mg product vials. Neogen received a number of reports of adverse events in horses following intraarticular injections of this product, which is inconsistent with its labeled, intended use. To date, Neogen has not received reports of adverse events when used in a manner consistent with the labeled use.
While the company’s investigation into this issue is ongoing, out of an abundance of caution the 2mL/20mg product vials are also being recalled. The company is proactively working with the FDA on this matter.
Risk Statement: This product is labeled as a sterile solution, but due to microbial contamination of certain lots, the recalled lots should no longer be considered sterile. Vials that contain a microbial contaminant potentially result in infection in the animal. The risk is particularly acute when used as an intraarticular injection (which is inconsistent with its labeled, intended use). There also is risk if used according to the label as a topical wound management system in surgical wounds, burns, ulcers, and autograft procedures. To date, Neogen has not received reports of adverse events when used in a manner consistent with the labeled use.
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