Indian Manufacturer Recalls Eyedrops Previously Cited in FDA Warning.

Indian manufacturer Kilitch Healthcare India has officially recalled over two dozen varieties of eyedrops that were subject to a safety warning from the U.S. Food and Drug Administration (FDA). The products were sold by national retailers such as CVS Health, Target, and Rite Aid. The FDA had already alerted stores to stop selling the drops due to the risk of vision loss or blindness. The FDA does not have the authority to force recalls, but relies on voluntary action from manufacturers. The FDA had previously recommended the recall on October 25. Kilitch Healthcare stated that it has not received any reports of adverse events related to its products. The FDA had issued a warning about the drops, citing unsanitary conditions and bacterial contamination at the manufacturing factory. The FDA is responsible for ensuring the safety of foreign products shipped to the U.S., but has faced challenges in keeping up with international pharmaceutical supply chains, particularly from India. The agency has been working to catch up on missed inspections during the COVID-19 pandemic. CVS Health has already stopped selling the recalled eyedrops and is offering refunds to customers. Target and Cardinal Health, another company that sells the products, did not respond to inquiries. Earlier this year, an outbreak of drug-resistant bacteria was linked to eyedrops from two different companies, resulting in eye infections, vision loss, and fatalities. The manufacturing plant in India that produced those drops was found to have issues with production and testing. [Extracted from the article]