Amidst bacterial outbreak, FDA issues second warning to Delsam Pharma’s Artificial Eye Ointment

The Food and Drug Administration (FDA) has issued a second warning against Deslam Pharama’s Artificial Eye Ointment and warned healthcare practitioners against purchasing the artificial tears product due to fear of potential bacterial contamination. The company has also agreed to initiate a recall of the over-the-counter product.

The ointment is manufactured by an India-based company called Global Pharma Healthcare Private Limited which has since then halted production after a late-night inspection earlier this month.

The FDA issued the initial warning at the beginning of February and instructed healthcare providers and consumers to stop purchasing and using Delsam Pharma’s Artificial Tears EzriCare Artificial Tears due to concerns regarding bacterial contamination. The usage of contaminated tears can lead to eye infections that can increase the risk of blindness and even death.

A multistate investigation in collaboration with the Centres for Disease Control and Prevention regarding the outbreak of Pseudomonas aeruginosa bacteria, a rare, extensively drug-resistant strain of bacteria had been conducted that revealed that so far 58 patients from 13 states have been identified.

As of the end of January, a total of 55 patients in 12 states had been identified as affectees of the bacterial contamination and associated adverse effects including one reported death due to bloodstream infection in Washington, one surgical removal of the eyeball, and five people who were permanently blinded. As of this week, 3 more patients have been identified and Illinois has been added to the list as the 13th state impacted. 

“We are actively gathering more information about long-term patient outcomes, particularly for patients with eye infections,” A CDC spokesperson said.

Opened bottles of EzriCare eye drops contaminated with the bacteria were found at the homes of multiple patients by investigators. Of the unopened bottles collected, 3 showed no signs of contamination, while the rest are being tested. In most of the cases linked to the outbreak the bottles of eye products were purchased online however, there was one instance where a patient had purchased a bottle from a Costco warehouse.

The agency’s demand for the recall of the products by Global Pharma is also linked to the company’s violations of current good manufacturing practices. The FDA has found that the company failed to conduct appropriate microbial testing and lacked proper controls regarding tamper-evident packaging which may have contributed to the outbreak. 

In addition to this, the FDA also identified formulation issues which essentially means that the company manufactures and distributes its product in multi-use bottles without the use of a proper preservative.

Since Global Pharma Healthcare Private Limited also failed to adequately respond to a records request and failed to comply with current good manufacturing practice requirements the FDA has placed them on an import alert which prevents the company’s goods from entering the U.S.

There is a state of nationwide high alert against the outbreak and people who may be suffering from symptoms of eye infection has been advised to seek out a  medical practitioner immediately. Consumers and healthcare professionals have been advised to report adverse reactions and events to the FDA through the agency’s Consumer Complaint Coordinators and FDA’s MedWatch Adverse Event Reporting program respectively. 

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