Wednesday, January 22, 2014

FDA recall questions the sterility of eye drops made in Vietnam

The FDA said Friday that Mentholatum is recalling a variety of over-the-counter eye drops after a review of manufacturing facilities raised questions of sterility. In another sign of the globalization issues facing the FDA, the drops being recalled were manufactured in Vietnam.

The recall is for Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, but only those that say, "Made in Vietnam." The Mentholatum Company, founded in Wichita, KS, was bought out in 1988 by Rohto Pharmaceutical, which bills itself as the second largest consumer health company in Japan.

With about 80% of active pharmaceutical ingredients used in U.S. drugs now coming from overseas, the FDA has been expanding its foreign plant inspections. Congress in 2012 gave it extra money to station staff around the world so that it could inspect foreign facilities at least as often as those in the U.S.

The FDA has focused a lot of that effort on China and India. The agency is adding 10 drug inspectors to its office in China to help oversee drug and ingredient producers whose products make it into the U.S. supply chain. It also has been adding staff in India and has taken a number of enforcement actions there against some of its largest manufacturers, like Ranbaxy Laboratories and Wockhardt. While not yet a significant manufacturing hub, Vietnam is one of the markets that drugmakers are looking to expand in as they look for growth markets to offset slow growth in the U.S. and Europe.

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