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# FDA Warning, Import Alert on Contaminated Eyedrops
- URL: https://www.fdaweb.com/fda-warning-import-alert-on-contaminated-eyedrops/
- Published: 2023-02-02T12:00:00.000Z
- Updated: 2026-09-14T18:14:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153695

FDA has issued an import alert and a safety warning on EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. The over-the-counter products are manufactured by Global Pharma Healthcare Private Limited in Tamilnadu, India. “Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the [agency alert](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

FDA says it placed the company on [import alert](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMzAyMDIuNzA5MjM0MDEiLCJ1cmwiOiJodHRwczovL3d3dy5hY2Nlc3NkYXRhLmZkYS5nb3YvY21zX2lhL2ltcG9ydGFsZXJ0XzE4OS5odG1sP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.wNSZg%5FqOak4KsXoxpq%5FG7pwbqpsTqxIS6yMhJeoOn1Y/s/1255931999/br/153927631571-l?ref=fdaweb.com) for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert is intended to stop the products from entering the U.S.

FDA says Global Pharma has issued a recall after the agency recommended it due to the company’s [current good manufacturing practice (CGMP)](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMzAyMDIuNzA5MjM0MDEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L2RydWdzL3BoYXJtYWNldXRpY2FsLXF1YWxpdHktcmVzb3VyY2VzL2N1cnJlbnQtZ29vZC1tYW51ZmFjdHVyaW5nLXByYWN0aWNlLWNnbXAtcmVndWxhdGlvbnM%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.l72faEwVl4ydshz8pqYL9c7hWhwgRb7lly3TO9OOiM0/s/1255931999/br/153927631571-l?ref=fdaweb.com) violations, “including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.”

The agency is working with the CDC and state and local health departments to investigate the multistate outbreak involving a rare, extensively drug-resistant strain of *Pseudomonas aeruginosa* bacteria. So far, CDC has identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence the products, the agency says.