Kinetic Technologies and Kinetic Vet Announce the Voluntary Nationwide Recall of Hy-Optic, OptiVet and Optimend Due to Deficiencies in Sterility
- Company Announcement Date:
- September 02, 2016
- FDA Publish Date:
- December 01, 2018
- Product Type:
- Animal & Veterinary
- Reason for Announcement:
- Company Name:
- Kinetic Technologies and Kinetic Vet
- Brand Name:
Brand Name(s)Hy-Optic, OptiVet, Optimend
- Product Description:
Product DescriptionIrrigating solutions and Corneal Repair Drops
Kinetic Technologies and Kinetic Vet located in Lexington, KY has voluntarily recalled Hy-Optic – lot # 10092015, OptiVet – lot # 12032015 and Optimend – lot # 01122015. This voluntary recall is the result of deficiencies in sterility, which may lead to deteriorating eye conditions, irritation and/or infection.
- Hy-Optic Eye Irrigating Solution – NDC # 51031-011-15, Lot # 10092015, Exp. Date 10/2017
- OptiVet Eye Irrigating Solution –- NDC # 51031-011-15, Lot # 12032015, Exp. Date 07/2017
- Optimend Corneal Repair Drops – NDC # 51031-013-10, Lot # 01122015, Exp. Date 10/2017
Each product is packaged in a branded box with the lot number and expiration date printed on the box. Hy-Optic Eye Irrigating Solution and OptiVet Eye Irrigating Solution are packaged in 15 mL oval eye drop containers and labeled prior to packaging. No animal species are listed on the label for use in non-specified animals. Optimend Corneal Repair Drops is packaged in a 10 mL circular eye drop container and labeled prior to packaging for use in dogs, cats and horses for the treatment of corneal ulcers.
The recalled products were distributed over-the-counter (OTC) nationwide through retail stores and through distributors by veterinarians for clinic use and dispensing to their patients.
Bacteria were detected in some of the samples. The product’s lack of sterility can lead to deteriorating eye conditions, irritation and/or infection and potentially, loss of sight.
To date, the company has not received adverse event reports attributable to the contamination of any of these products.
As a safety precaution the company is conducting a voluntary recall and will continue to closely monitor for reports of adverse drug reactions and product complaints.
The U.S. Food and Drug Administration is aware of this recall. Notification of the recall has been sent to distributors.
Consumers who have purchased Hy-Optic, OptiVet and Optimend should stop using the product(s) at once and may return product(s) to the place of purchase for a full refund. If the treated eye is unimproved or the condition has worsened, owners should consult with a veterinarian for further diagnosis and appropriate treatment. Untreated eye conditions may result in pain and potential loss of eyesight. Vision loss which is complete or partial and temporary or permanent. Consumers with questions or adverse events to report may contact the company at 1-877-786-9882 M-F 8:30 am – 5:00 pm. Adverse events associated with these, or other products for use in animals, may also be reported directly to the FDA by following information provided here:http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm