J&J Stops Tylenol Production in South Korea

J&J Stops Tylenol Production in South Korea

May 6th, 2013 // 12:46 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Johnson and Johnson has come up with a new PR campaign to help us overlook the huge number of recalls and scandals in recent years. But no PR campaign is going to be a substitute for improving GMP manufacturing procedures. And these mistakes just keep coming.

The latest manufacturing snafu is happening in South Korea. The Janssen unit there was told to stop production of Children’s Tylenol syrup because J&J was in violation of cGMP guidelines, with many problems tied to poor senior management oversight.

This is one week after the firm recalled 175 batches of Children’s Dye-Free Tylenol because some bottles had a higher amount of active ingredient, which is acetaminophen. The higher dose could cause liver damage. J&J faces up to six months of suspension of production for breaking cGMP rules in South Korea.

A Ministry of Food and Drug Safety spokesman stated that drug manufacturers are usually prohibited from making drugs for months when there are problems with manufacturing. The spokesman also noted that the drugs affected are sold only in South Korea. J&J reported the problem to Ministry headquarters, and experts from that Ministry went to the factory to help to solve all cGMP problems.

Given the recent track record of J&J, this could go on for months. J&J is still working to fix a key manufacturing plant in Pennsylvania after that plant had several embarrassing recalls.

J&J also recently signed a consent decree with the US FDA and is fighting lawsuits over hip implant recalls.

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