Kilitch Healthcare India is voluntarily recalling its eye drops, under multiple brands, due to potential safety concerns after the U.S. Food and Drug Administration (U.S. FDA) investigators found insanitary conditions.
For patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile, the U.S. FDA said, describing the products the Mumbai firm is recalling as lubricant eye drops and multi-symptom eye drops. They are being recalled to the consumer level with all lots within expiry and expiration dates ranging from November 2023 to September 2025.
The regulator, however, did not elaborate on the insanitary conditions found by its investigators. Last month, without naming the company, it had issued a warning to consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness.
The U.S. FDA said it had advised the manufacturer of the products to recall all lots after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.
In the release on the recall, by Kilitch Healthcare India, the regulator said the products were distributed the U.S. to wholesalers, retailers and via the product distributor, Velocity Pharma LLC.
Earlier this year, U.S. Centers for Disease Control and Prevention (CDC) had linked Global Pharma Healthcare’s eye drops to a clutch of adverse events in the U.S., following the Chennai-based announced a voluntary recall.
The Food and Drug Administration, however, did not elaborate on the insanitary conditions found by its investigators. | Photo Credit: ANDREW KELLY
Sri Lanka had also directed Gujarat-based Indiana Ophthalmics LLP to recall eye drops in the backdrop of usage of the product linked to eye infections in some people. It also resulted in pharma exporters body Pharmexcil seeking an explanation from the company.
