Neogen Recalls HYCOAT Solution for Contamination Risk

Neogen Corporation has announced a voluntary recall of its Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution due to potential microbial contamination. This recall affects all lots within expiry and is being conducted at the veterinarian level.

Products Affected:

• 2 mL/20 mg vials (UPC Code 726087089386) - 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 vials (UPC Code 726087089393) - Lot numbers: 0136731, 0736777, 0346843, 5A001

Reason for Recall:

The recall was initiated due to microbial contamination found in certain lots, which compromises the sterility of the product. This poses a risk of infection, particularly when used as an intraarticular injection, which is not the intended use according to the product label. The product is intended for topical wound management.

Consumer Actions:

Veterinarians and distributors are advised to discontinue use and quarantine the affected products. Neogen is notifying its customers and arranging for the return of the recalled products. For return instructions, customers can contact Neogen Animal Safety Customer Support at 859-254-1221 or email [email protected].

Health Risks:

While no adverse events have been reported when used as labeled, using contaminated vials can lead to infections. Veterinarians who have experienced issues should report them to the FDA's Center for Veterinary Medicine using Form FDA 1932a.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration, and no other Neogen products are affected.