2 Firms Warned on Veterinary Product Linked to Horse Deaths

FDA has issued Warning Letters to Neogen Corp. and Sciarra Aeromed Inc. after an investigation linked fungal contamination in a veterinary wound-care product to serious infections in nearly 100 horses and at least 20 deaths. An agency notice says Neogen Vet HYCOAT, a hyaluronate sodium solution labeled as sterile, was contaminated with multiple fungi. Veterinarians had reported using the product as an injection, although it was marketed as a topical veterinary device.

Nearly 100 horses developed serious joint infections after receiving the product, and at least 20 were euthanized after treatment failed. FDA said the incident represents the largest number of horse deaths associated with a quality defect in an FDA-regulated veterinary medical product.

An FDA inspection of the manufacturing facility found serious violations, including production of products labeled as sterile under insanitary conditions.

Neogen voluntarily recalled HYCOAT in January. FDA notes it became aware of the emerging problem through voluntary reports from veterinarians because Neogen, which marketed HYCOAT as an animal device, did not proactively report the adverse events to the agency.