A salt form of hyaluronic acid, hyaluronate sodium is a clear, gel-like substance the body naturally makes that acts like a water-holding sponge and shock-absorbing lubricant. It is used in medical and cosmetic products such as eye drops, joint injections, wound dressings and dermal fillers. For investors, its presence in a product can drive demand, pricing and regulatory scrutiny because it often determines how well a treatment relieves pain, protects tissues or improves appearance.
intraarticularmedical
Within a joint — the space where two bones meet — used to describe injections, implants or procedures delivered directly into that joint space. For investors, whether a therapy or device is intraarticular matters because direct delivery can change how well a treatment works, its side-effect profile, manufacturing and regulatory requirements, and market positioning; think of it like watering a plant’s roots directly rather than sprinkling the leaves.
topical wound management systemmedical
A topical wound management system is a set of products applied directly to skin wounds—such as dressings, gels, antimicrobial coatings or delivery devices—designed to protect the wound, control moisture and infection, and support faster healing. Investors watch these systems because their clinical performance, regulatory approval, manufacturing complexity and reimbursement potential determine how widely they will be adopted and how much revenue and profit they can generate, much like a better protective case reduces damage and repair costs for a device.
autograftmedical
An autograft is tissue taken from one part of a patient’s own body and moved to another part to repair or replace damaged tissue, like moving furniture from one room to another in the same house. It matters to investors because autograft procedures affect market demand, clinical outcomes, device and hospital revenues, and reimbursement rules — advantages in safety or effectiveness can lower costs, reduce complications, and influence adoption versus synthetic or donor alternatives.
upc codetechnical
A UPC code is the small barcode and numeric label printed on retail products that uniquely identifies a specific item and its package size—like a product’s fingerprint. Investors care because UPCs let companies, retailers and analysts track sales, inventory and distribution down to individual items, turning shelf activity into reliable data that affects revenue forecasts, supply-chain efficiency and decisions about marketing, pricing and product launches.
u.s. food and drug administrationregulatory
The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.
center for veterinary medicineregulatory
A Center for Veterinary Medicine is the regulatory office that evaluates and oversees the safety and effectiveness of medicines, medical devices, and food additives for animals. Think of it as a gatekeeper that decides which animal health products can be sold and under what rules; those decisions shape market access, product labeling, approval timelines, and the risk of recalls, all of which directly affect a company’s sales prospects and investor value.
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:
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 ET 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.”
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.
About Neogen
Neogen Corporation is committed to fueling a brighter future for global food security through the advancement of human and animal well-being. Harnessing the power of science and technology, Neogen has developed comprehensive solutions spanning the Food Safety, Livestock, and Pet Health & Wellness markets. A world leader in these fields, Neogen has a presence in over 140 countries with a dedicated network of scientists and technical experts focused on delivering optimized products and technology for its customers.
