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Repeated recalls of eyedrops are drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas.
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U.S. health inspectors found a host of sanitation and manufacturing problems at an Indian plant that recently recalled eyedrops sold in the U.S.
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The teen was born with a rare genetic condition that causes blisters all over his body and in his eyes. But his skin improved when he joined a clinical trial to test the world’s first topical gene therapy. His doctor wondered if it could be adapted for his eyes.
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The CDC has identified 81 patients in 18 states, including Florida, with the rare strain of P. aeruginosa. This represents an increase of 13 patients since the last update.
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FDA inspectors found about a dozen problems with how Global Pharma Healthcare made and tested the drops during a "deficient manufacturing process” at a plant in India.
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The FDA posted separate recall notices for certain eyedrops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market.
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Some nasty eye infections in California led health officials to link a superbug bacteria to potentially contaminated eyedrops imported from India. At last count, 58 Americans in 13 states have been infected.