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Manufacturer of OTC ocular products to cease manufacturing, distributing
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WASHINGTON — A manufacturer of over-the-counter ocular drops has signed a consent decree with the Food and Drug Administration to cease manufacturing and distributing drugs until it corrects “deficiencies and other violations” at a manufacturing facility, according to the FDA.
MBI Distributing, also known as Molecular Biologics, manufactures and distributes eye drop products under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein and Can-C. Among other violations, the FDA has determined that the Visitein and Clarity Vision for Life products are unapproved drugs.
The company has been manufacturing eye drops at its Benecia, Calif., facility in a manner that “does not conform to FDA’s current good manufacturing practice requirements,” an FDA press release said. The company has not corrected violations noted during inspections, including a lack of manufacturing controls to ensure the sterility of its eye drops, the release said.