CDSCO halts production of EzriCare Artificial Tears eye drops in the US after 55 adverse incidents

EzriCare Artificial Tears

After the Food and Drug Administration (FDA) of the United States allegedly linked 55 adverse event cases with contaminated EzriCare Artificial Tears eye drops, the Central Drugs Standard Control Organization (CDSCO) suspended eye drop production. Besides, the investigating agencies in both countries have been actively looking into the matter since the previous day.

People with knowledge of the situation claim that the US FDA has advised consumers “not to purchase or use EzriCare Artificial Tears due to potential contamination” and that the CDSCO of the Union Health Ministry and the State Drug Controller of Tamil Nadu have launched investigations into the matter.

“Teams of three people each from CDSCO and the TN State Drug Controller are traveling to the manufacturing facility close to Chennai. It is a contract manufacturing facility that supplies the US market through third parties. India does not sell this specific medication, “It read. The FDA has also barred the importation of goods made by Global Pharma Private Healthcare Limited, which is situated in Chennai. The FDA warned consumers and healthcare professionals not to buy and to cease using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears owing to possible bacterial contamination. The import alert stops these items from entering the United States. Using tainted artificial tears raises the risk of eye infections, which can be fatal or cause blindness.”

These OTC medications are made by Global Pharma Healthcare Private Limited and are meant to be “sterile. All unexpired batches of the artificial tears sold under the brand names EzriCare and Delsam Pharma are being voluntarily recalled by Global Pharma at the consumer level. Furthermore, it stated that as of January 31, 2023, the CDC had identified 55 people in 12 states who had infections that had been connected through epidemiological and laboratory evidence to the use of EzriCare Artificial Tears.

Hospitalization, one death from a bloodstream infection, and irreversible vision loss from eye infections are some of the adverse events connected. In light of recent warnings from the CDC and FDA, users are advised to discontinue using EzriCare Artificial Tears. Global Pharma Healthcare Private Limited was also placed on import alert by the FDA because it did not adequately respond to a records request and did not follow CGMP guidelines. Following the company’s recall of an eye drop related to vision loss in the US, two teams from the central and state drug regulatory bodies will examine Global Pharma Healthcare’s manufacturing facility close to Chennai, according to official sources on Friday.

“Teams of three from the State Drug Controller and CDSCO (Central Drugs Standard Control Organization) are en route to the plant, which is around 40 km south of Chennai. It is a contract manufacturing facility that supplies the US market through third parties. One of the reports claimed that India does not sell this particular medication. According to a statement from the US FDA, all lots of the Artificial Tears lubricating eye drops provided to consumers by EzriCare, LLC and Delsam Pharma are being recalled owing to suspected contamination. It stated that there have been 55 reports of negative side effects to date, including eye infections, permanent vision loss, and one death from a bloodstream infection. According to the US FDA, using tainted artificial tears puts users at risk for eye infections that could lead to blindness. Artificial Tears eye drops are used to lubricate the eyes and prevent them from irritation or dryness.

Artificial Tears eye drops are used to lubricate the eyes and prevent them from irritation or dryness. Global Pharma Healthcare said in a statement on its website that it has notified the product’s distributors, Aru Pharma Inc. and Delsam Pharma, and that it is recommending that wholesalers, retailers, and customers who have the recalled product avoid using it. It advised customers to get in touch with their doctor or healthcare provider if they had any issues that might have been brought on by using these OTC medications.

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