FDA ISSUES WARNING ABOUT EZRICARE ARTIFICIAL TEARS AND DELSAM PHARMA’S ARTIFICIAL TEARS

February 6, 2023

On Feb. 2, 2023, the Food and Drug Administration (FDA) warned consumers not to purchase and to immediately stop using over-the-counter EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears — which are manufactured by Global Pharma Healthcare Private Limited in India[1] and sold by Walmart and Amazon[2] — because of potential bacterial contamination.[3] The agency cautioned that using contaminated artificial-tears products could result in blindness or death.

The FDA warning was prompted by an ongoing joint investigation by the FDA, Centers for Disease Control and Prevention (CDC), and state and local health departments of a multistate infectious disease outbreak involving a rare strain of a bacteria known as Pseudomonas aeruginosa that is resistant to most available antibiotics. The CDC issued its own alert on Feb. 1, 2023, which noted that the agency had identified 55 patients in 12 states with extensively drug-resistant Pseudomonas aeruginosa infections linked to use of EzriCare Artificial Tears.[4] Infections seen in these patients included serious eye infections involving the cornea or fluids inside the eye, respiratory infections, urinary tract infections and sepsis. One patient died due to widespread infection in the body.

According to the CDC, most of the patients reported using one or more brands of artificial tears, with the majority of these patients reporting use of EzriCare Artificial Tears from multidose bottles that did not contain any preservatives. In addition, the CDC identified the presence of the outbreak-causing strain of bacteria in opened bottles of EzriCare Artificial Tears from different lot numbers collected in two states.

In response to an FDA recommendation, Global Pharma Healthcare initiated a voluntary recall of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.[5] The agency recommended this recall after it had identified violations of required manufacturing practices that are intended to ensure that such products meet standards for quality and sterility. The agency also took action to prevent importation of these products into the U.S.

If you are using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears, stop using them immediately.

To see the FDA’s warning, visit the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.

To see the CDC’s alert, visit the following link: https://emergency.cdc.gov/han/2023/han00485.asp.
 

References

[1] EzriCare. EzriCare Artificial Tears - Discontinue use. February 2, 2023. https://ezricare-info.com/. Accessed February 6, 2023.

[2] Tin A. FDA faults company behind recalled eye drops for multiple violations, bans imports. February 2, 2023. https://www.cbsnews.com/news/recall-eye-drops-infection-fda-global-pharma-multiple-violations-import-ban-ezricare-delsam/. Accessed February 6, 2023.

[3] Food and Drug Administration. FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination. February 2, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination?utm_medium=email&utm_source=govdelivery. Accessed February 6, 2023.

[4] Centers for Disease Control and Prevention. Health Alert Network. Outbreak of extensively drug-resistant Pseudomonas aeruginosa associated with artificial tears. February 1, 2023. https://emergency.cdc.gov/han/2023/han00485.asp. Accessed February 6, 2023.

[5] Food and Drug Administration. FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination. February 2, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination?utm_medium=email&utm_source=govdelivery. Accessed February 6, 2023.