Kilitch Healthcare India Limited is voluntarily recalling the eye drops 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. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.
Risk Statement: 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 potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. 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 Limited, 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 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 any of the above listed products to the place of purchase.
Consumers with questions regarding this recall can contact [email protected] or [email protected]
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
See the full recall here.