J&J issue in South Korea reminiscent of OTC problems here

Drugmakers hope to export their success to emerging markets so they can reap big rewards, but Johnson & Johnson's ($JNJ) Janssen unit appears to have taken a backward approach in South Korea, where it is in hot water over a recall of Children's Tylenol products.

J&J has had notorious problems in its OTC manufacturing in the U.S. that resulted in the recall of millions of products and led to an FDA consent decree. The Daily Pharm in South Korea reports that Janssen last week was ordered 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. This week the unit was ordered to halt production of the products for several months, a standard response to recalls, according to The Korea Times.

South Korea's Ministry of Food and Drug Safety (MFDS) said in a statement that the suspension followed the violation of several regulations by Janssen. It didn't report the problem quickly, delaying the recall by a month. It also violated quality-control regulations there, The Korea Times reports. An audit found that the company had manually filled containers with the ingredient because a filling machine wasn't working properly, Daily Pharm said.

J&J is just now scurrying out from under the cloud of mishaps tied to OTC manufacturing in the U.S. During a recent earning 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 South Korea Times story
- see more from Daily Pharm

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