Neogen Corporation has announced a voluntary nationwide recall of all lots within expiry of its NeogenVet HYCOAT Hyaluronate Sodium Sterile Solution, used for dogs, cats, and horses. The recall is directed to the veterinarian level and covers both 2mL/20mg and 10mL/50mg vials. The company distributes this product, which is manufactured by a third-party supplier.
The recall was initiated after microbial contamination was detected in certain lots of the 10 mL/50 mg vials. According to Neogen, "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."
As an added precaution while the investigation continues, Neogen is also recalling the 2mL/20mg vials. The company stated it is working closely with the U.S. Food and Drug Administration (FDA) on this matter.
The product is labeled as a sterile solution but due to microbial contamination in some lots, those lots are no longer 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," Neogen said. However, there have been no reports of adverse events when used according to label instructions.
The affected products were distributed nationwide to animal health distributors and veterinarians. Neogen has notified distributors and direct customers by email and is arranging for return of all recalled products. Users are advised to discontinue use and quarantine any recalled HYCOAT products.
Veterinarians who encounter problems related to this product are encouraged to report them using FDA’s Center for Veterinary Medicine Form FDA 1932a or by contacting FDA at 1-888-FDA-VETS.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration," according to Neogen.
No other products from Neogen are impacted by this action.
