India’s drug regulator has suspended the production of all eye care products at Global Pharma Healthcare, based in Chennai, due to the US Food and Drug Administration (FDA) linking the death of at least one person and 55 infections to the company’s product. The decision was made following a joint inspection with state authorities and was based on a preliminary report submitted by the Central Drugs Standard Control Organization (CDSCO). The inspection took place Friday night and the company was told to halt all production of ophthalmic products until the investigation is completed. The US Centers for Disease Control and Prevention (CDC) also sent a health alert to doctors, advising people not to use or purchase EzriCare Artificial Tears manufactured by Global Pharma Healthcare. The product caused infections of a drug-resistant bacteria leading to permanent vision loss for some people. In response to the FDA warning, Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops. Samples of the raw materials used in the eye drops have been collected and sent to labs in Tamil Nadu for analysis. The company is licensed and followed proper channels for exporting their products. The joint investigation report by the CDSCO found that the company exported two consignments of 24 batches of artificial tears to the US. The CDC is also testing unopened bottles of the eye drops. The FDA issued a warning to consumers and healthcare practitioners due to potential bacterial contamination and pointed out multiple violations by the company.
India Suspends Production of Global Pharma Healthcare Eye Products After US FDA Link to Infections and Death
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