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J&J dealing with OTC manufacturing issues on 3 continents

Suspension in Korea follows recall of Children's Tylenol products with excessive acetaminophen
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Prescription drugs may be more involved to make than over-the-counter products, but a manufacturing problem is a problem either way and just as likely to get a company in trouble with regulators. Johnson & Johnson ($JNJ) has been getting a hard reminder around the world of that fact in recent days.

Regulators in South Korea made J&J's Janssen unit halt production of Children's Tylenol Suspension last week after having it recall the over-the-counter product because it exceeded specifications for an active ingredient. And now regulators yanked J&J's license to make cosmetics at a Mumbai-area plant after they found that the company had used an unauthorized sterilization process on baby powder.

In South Korea, the Ministry of Food and Drug Safety (MFDS) ordered Janssen to recall all of its Children's Tylenol Suspension 100-ml and 500-ml products because they contained excessive levels of acetaminophen, a problem that can lead to liver damage, the Daily Pharm reported. According to The Korea Times, the production interruption is a standard response to recalls and could last several months. The MFDS said in a statement that the suspension followed the violation of several regulations by Janssen. It also violated quality-control regulations and then didn't report the problem quickly, delaying the recall by a month. An audit found that the company had manually filled containers with the ingredient because a filling machine wasn't working properly, Daily Pharm said. The unit has called in experts to get its filling line back in order.

In Mumbai, Reuters reports that the Maharasthra Food and Drug Administration took action after discovering that J&J used ethylene oxide to kill bacteria in its baby powder, but hadn't conducted mandatory tests to make sure no residue remained. 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 company said there were no consumer complaints or adverse events reported. The Mumbai 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.

The missteps in South Korea and India come even as J&J is getting on top of the long-running OTC problems in the U.S., where it is operating under a consent decree with the FDA. During a recent earnings call, CFO Dominic Caruso said the OTC business in the U.S. was up more than 14% in the first quarter after several years of backsliding there. In 2011, J&J's McNeil Consumer Healthcare signed an FDA consent decree after two years in which it recalled tens of millions of consumer products, including its popular Tylenol and Motrin products. J&J has spent more than $100 million to upgrade its key OTC plant here and has reportedly lost billions of dollars in sales because it has been unable to keep stores stocked with popular brands. Caruso said J&J has been ramping up production and expects to have 75% of its OTC brands back in stores by the end of this year.

- read the Korea Times story
- see more from Daily Pharm 
- see the Reuters news

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