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LANSING, Mich. – Neogen Corporation has voluntarily recalled all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level.
According to Neogen, the 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.
The product is intended for use as a topical wound management system and is packaged in vials of 2mL/20 mg (UPC Code 726087089386) and 10mL/50mg (UPC Code 726087089393).
The subject product lots within expiry include the following:
2 mL/20 mg lot numbers: 0236735, 0236736, 0336746, 0336747, 0536760, 0536761, 0636768, 0636769, 0836792, 0836785, 0836788, 0836789, 0936794, 0936795, 1036801, 1036802, 1036803, 1036804, 1136807, 1136808, 0246837, 0246838, 4L001B, 4L002
10 mL/50 mg lot numbers: 0136731, 0736777, 0346843, 5A001.
Neogen is notifying its distributors and direct customers by email and is arranging for return of all recalled products. Anyone that has HYCOAT which is being recalled should discontinue use and quarantine product.
Customers with questions regarding this recall can contact Neogen Animal Safety Customer Support Monday through Friday, 8AM-5PM EDT at 859-254-1221 or via email at AnimalHealth@neogen.com for return shipping instructions. Customers can work through their distributor for product returns.
Veterinarians that have experienced any problems that may be related to using this product should report to the FDA's Center for Veterinary Medicine on FORM FDA 1932a, “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report.”
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