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.
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®Vet HYCOAT® Hyaluronate Sodium Sterile Solution was distributed nationwide to animal health distributors and veterinarians.
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.”
- Download and submit Form FDA 1932a available at https://www.fda.gov/reportanimalae, or
- Contact FDA at 1-888-FDA-VETS to request this form.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
No other Neogen products are affected by this field action.
