Indian watchdogs pull J&J plant's license on baby-powder sterilization issue

Johnson & Johnson is busy negotiating with Asian regulators these days. As FiercePharma reported Friday, South Korean regulators forced the company to halt production at an over-the-counter drug plant. Apparently, Indian watchdogs were doing the same at a consumer healthcare facility in their country.

As Reuters reports, health officials pulled J&J's ($JNJ) license to make cosmetics at a Mumbai-area plant after they found that the company had used an unauthorized sterilization process on baby powder. The company said there were no consumer complaints or adverse events reported. But that didn't stop the Maharasthra Food and Drug Administration from putting the kibosh on production.

The state FDA said J&J used ethylene oxide to kill bacteria in its baby powder, Reuters said, but hadn't conducted mandatory tests to make sure no residue remained. Exposure to the substance, used to make industrial chemicals and sterilize medical equipment, can cause a variety of health problems, including lung damage and nausea.

Typically, baby powder is sterilized using steam, J&J spokeswoman Peggy Ballman told the news service in a statement. The ethylene oxide process was used once, on a limited amount of the product, she said. The process is "widely accepted and safe" and "leaves no harmful residue," she said, but it wasn't registered with local regulators. "[T]hey viewed this step as out of compliance," she said.

The plant hasn't been shut down, and J&J has appealed the revocation of its license. The baby powder made there is sold only in India. But with headlines made elsewhere, the plant snafu adds to the list of quality-control missteps at the company. J&J's OTC drugs business has been struggling to recover from a long series of recalls, including a massive withdrawal of children's remedies that left drugstore shelves bare of key J&J brands. The South Korean recall adds to the list of Tylenol product shortfalls, with some children's liquid containing excessive amounts of the drug's active ingredient, acetaminophen.

J&J's public relations problems in its baby-products business haven't been limited to drugs, either. Activists called on the company to remove potentially harmful ingredients from its baby products, including the widely sold Baby Shampoo. The company agreed to phase out the ingredients over two years, beginning in late 2011. The Campaign for Safe Cosmetics had been lobbying the company for changes for some time.

- see the Reuters news

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