Neogen recalls veterinary hyaluronate solution due to contamination
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Neogen Corporation (NASDAQ: NEOG) issued a voluntary nationwide recall of all lots within expiry of Neogen Vet HYCOAT Hyaluronate Sodium Sterile Solution for dogs, cats, and horses due to microbial contamination in certain lots.
The company received reports of adverse events in horses following intraarticular injections of the product, which represents off-label use. The product is intended for topical wound management in surgical wounds, burns, ulcers, and autograft procedures. Neogen has not received reports of adverse events when the product was used according to its labeled instructions.
The recall affects both 2mL/20mg and 10mL/50mg product vials. The contamination was identified in certain lots of the 10mL/50mg vials, but the company included the smaller vials in the recall as a precautionary measure while its investigation continues.
Recalled lot numbers include 24 lots of the 2mL/20mg vials and four lots of the 10mL/50mg vials. The product was distributed nationwide to animal health distributors and veterinarians.
The contamination poses infection risks to animals, particularly when used as intraarticular injections. The company stated that vials containing microbial contaminants should no longer be considered sterile and present risks even when used topically as labeled.
Neogen is working with the FDA on the matter and notifying distributors and customers by email. The company has arranged for the return of all recalled products and advised customers to discontinue use and quarantine any affected inventory.
The product is manufactured by a third-party supplier. No other Neogen products are affected by this recall, according to the company's statement.
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