India Seeks Clarity from FDA On Alleged Contamination of Eye Drops - medtigo



India Seeks Clarity from FDA On Alleged Contamination of Eye Drops

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On Tuesday, the Drugs Controller General of India (DCGI) wrote to the U.S. Food and Drug Administration (USFDA) seeking details about a drug-resistant bacteria strain allegedly linked to eye drops imported from India that may have established a foothold in U.S. health care settings, according to sources in the Health and Human Services (HHS).  

Following reports of contamination, the manufacturer of EzriCare eye drops, Chennai-based Global Pharma Healthcare, is recalling 50,000 tubes from the American market, according to the U.S. Food and Drug Administration. According to the source, Global Pharma Healthcare has been instructed to cease production of ophthalmic products until the investigation is concluded.  

“So far, none of the company’s samples have been found to be contaminated,” the source told The Hindu, adding, “Samples were collected by a joint Central-State team, and the results have been shared with the relevant department.” According to a preliminary report, the samples lack contamination. In the United States, opened bottles have been linked to the alleged contamination. The eye drops are distributed in the United States by Delsam Pharma of New York.  

According to sources within the State Drugs Control Department, the quality of the eye drops’ raw materials was deemed to be standard. The official stated to The Hindu, “We are closely monitoring the investigations and moving the matter forward.”  

This year, ErziCare Artificial Tears was linked to over 50 reports of adverse events in 12 U.S. states, including eye infections, permanent vision loss, and a bloodstream infection-related death. Global Pharma Healthcare subsequently recalled its manufactured product.  

Previously, the CDC had advised patients to discontinue use of the eye drops pending additional information and direction from the CDC and FDA. The CDC added that there was no recommendation for testing patients who had used the product but were not exhibiting infection-related symptoms.

Eye infection symptoms included yellow, green, or clear discharge from the eye; pain or discomfort; redness of the eye or eyelid; a feeling of something in the eye (foreign body sensation); increased light sensitivity; and blurred vision. 


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