FDA expands recall of eye drops linked to bacterial contamination

Eye drops recall expansion overview: 

• Who: Global Pharma Healthcare Private Limited has expanded a recall of its EzriCare & Delsam Pharma Artificial Tears Lubricant Eye Drops to include its Delsam Pharma Artificial Eye Ointment.
• Why: The recall was initiated over concerns the products were contaminated with the extensively drug-resistant bacteria Pseudomonas aeruginosa, which has so-far been linked to five cases of permanent blindness and one death. 
• Where: The recall is nationwide. 

The U.S. Food and Drug Administration (FDA) has expanded its eye drops and ointment recall and told consumers to stop using Delsam Pharma’s Artificial Eye Ointment due to a possible contamination with bacteria that has been linked to cases of blinding. 

India-based Global Pharma Healthcare Private Limited, the manufacturer for Delsam Pharma’s Artificial Eye Ointment, has also agreed to recall the product following a recommendation by the FDA, WHIO TV 7 reports.  

Global Pharma Healthcare announced a separate recall earlier this month for all lots of its EzriCare & Delsam Pharma Artificial Tears Lubricant Eye Drops over concern the product had suffered a microbial contamination. 

That recall was attributed to the same bacteria, Pseudomonas aeruginosa, that, according to WHIO TV 7, the FDA is now worried may have contaminated the Delsam Pharma Artificial Eye Ointment.

The FDA has previously faulted Global Pharma Healthcare for committing multiple violations regarding other products and has since banned the import of its items coming into the U.S., reports WHIO TV 7. 

CDC issued health alert warning over Pseudomonas aeruginosa outbreak it linked to Ezricare artificial tear products

Both recalls come in the wake of a health alert warning released by the U.S. Centers for Disease Control and Prevention (CDC) on Feb. 1 in regard to an outbreak of Pseudomonas aeruginosa that was linked back to EzriCare artificial tears products. 

The CDC warned Pseudomonas aeruginosa is “extensively drug-resistant” and using eye drops contaminated with the bacteria could lead to a number of adverse health effects, including permanent vision loss. 

As of Feb. 21, a total of 58 patients have been identified as having health problems linked to exposure to Pseudomonas aeruginosa, with at least 16 having to undergo hospitalization as a result, according to the CDC, WHIO TV 7 reports. 

Five of the patients who were hospitalized due to exposure to Pseudomonas aeruginosa have reportedly suffered permanent blindness, while WHIO TV 7 reports a Washington state patient died after the infection got into their bloodstream. 

A class action lawsuit was filed earlier this month against several companies — including Global Pharma Healthcare and Ezricare LLC — by a consumer arguing they had manufactured and sold adulterated and contaminated eye drop products.  

Have you recently used an Ezricare or Deslam Pharma artificial eye drop product? Let us know in the comments.

If you or a loved one suffered from a bacterial infection, vision loss, other injury or death after using EzriCare or Delsam eye drops or Delsam eye ointment, you could be eligible to join a class action lawsuit investigation. Find out more.

Read About More Class Action Lawsuits & Class Action Settlements:

• Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms recall initiated due to undeclared nuts
• Do you have potential fire hazards at home? Check this list of recent recalls
• Hand sanitizer recalled due to methanol contamination
• ProSobee Simply Plant Based Infant Formula recalled due to possible bacterial contamination