Kilitch Healthcare India Recalls Various Eye Drops In US For Safety Concerns
Kilitch Healthcare India is voluntarily recalling the eye drop products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November 2023 to September 2025 for all the below-mentioned products, the United Foods and Drugs Administration (USFDA) said in a statement on Friday.
As many as 27 products of different sizes and compositions subsuming lubricant eye drops and multi-symptom eye drops are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.
USFDA states that for those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defences.
The global regulator however added that to date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. Kilitch Healthcare India is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for the return of all impacted products listed above.
"Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return products to the place of purchase," the USFDA stated in its statement.
