Neogen Issues Voluntary Nationwide Recall of Neogen® Vet HYCOAT® Hyaluronate Sodium Sterile Solution Due to Microbial Contamination

Neogen Corporation of Lansing, Michigan, is voluntarily recalling certain lots of Neogen® Vet HYCOAT® Hyaluronate Sodium Sterile Solution due to potential microbial contamination.

According to the company announcement posted by the U.S. Food and Drug Administration (FDA), the recall was initiated after microbial contamination was identified in certain vials. 

The product is labeled sterile, but contamination could cause infection when administered.

Product Included in the Recall

  • Product Name: Neogen® Vet HYCOAT® Hyaluronate Sodium Sterile Solution
  • Product Type: Animal & Veterinary
  • Intended Use: Veterinary use for dogs, cats, and horses
  • Packaging: Vials
    • 2 mL / 20 mg
    • 10 mL / 50 mg

The recall applies to all lots of the affected product that are within their expiry date.

Health Risk Information

The recalled product is labeled as sterile. Microbial contamination of sterile injectable products may pose an infection risk in animals upon administration.

According to the FDA announcement, Neogen has received reports of adverse events in horses following intra-articular injections of the product when used in a manner inconsistent with its labeled use. 

No adverse events have been reported when the product has been used in a manner consistent with the labeled use.

Pet owners and veterinarians should monitor animals for signs of infection or adverse reactions. 

Veterinarians who observe potential adverse events related to this product should report them to the FDA’s Center for Veterinary Medicine.

Distribution

Neogen® Vet HYCOAT® Hyaluronate Sodium Sterile Solution was distributed nationwide to animal health distributors and veterinarians.

What Consumers and Veterinarians Should Do

  • Discontinue use of the recalled product immediately
  • Quarantine the product if it is in inventory
  • Arrange for the return of all recalled products

Neogen is notifying its distributors and direct customers by email and is coordinating the return of recalled products.

Additional Information

No other Neogen products are affected by this recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Consumers and veterinarians with questions regarding this recall may contact Neogen Corporation at:

  • Phone: (859) 254-1221
  • Email: AnimalHealth@neogen.com
  • Availability: Monday through Friday, 8:00 a.m. to 5:00 p.m. EST

For complete recall details, please refer to the FDA announcement.