Neogen Corporation (NASDAQ: NEOG), Lansing, MI, recalled 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 manufactures. 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 intra-articular 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 accordance 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. This product is labeled as a sterile solution, but due to microbial contamination in certain lots, those lots should no longer be considered sterile. The risk is particularly acute when used as an intra-articular injection (which is inconsistent with its labeled, intended use). There is also a risk when 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 accordance with the labeled use. Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution was distributed nationwide to animal health distributors and veterinarians. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/neogen-issues-voluntary-nationwide-recall-neogenrvet-hycoatr-hyaluronate-sodium-sterile-solution?utm_medium=email&utm_source=govdelivery
