J&J appeals OTC plant license revocation in India

Johnson & Johnson ($JNJ) has appealed to a higher authority in India in hopes it will reverse a plant suspension by state authorities that were peeved that Johnson & Johnson's OTC operation did not give them a heads up about a manufacturing change for sterilizing baby powder in 2007. J&J is asking the Maharashtra government to overrule the decision by the state's Food and Drug Administration, moneycontrol.com reports. The company explained it used the ethylene oxide to sterilize about 150,000 bottles of powder one time, when its normal steam process was not available. The company has said it appreciates the action by the state FDA but that "The product's safety was not compromised at any point and there were no adverse reports or complaints related to this issue." The OTC problem in India is only of several OTC manufacturing problems it is facing in different parts of the world. There is a criminal investigation in South Korea into the fact that its Janssen unit there had to manually fill some Children's Tylenol, resulting in it containing more than the labeled amounts of acetaminophen. It recently had to recall 19 lots of Tylenol drops in Brazil because of potential problems with the dispenser. Story | More