Mass recall of overly strong Children’s Tylenol

The Ministry of Food and Drug Safety yesterday ordered Janssen Korea, a subsidiary of Johnson & Johnson, to recall Children’s Tylenol Suspension citing manufacturing flaws that can trigger an increase in the drug’s active ingredient.

The recall will affect some 1.6 million bottles of the liquid painkiller and anti-inflammatory manufactured after May 2011 that might contain 20 to 50 percent more acetaminophen than normal, which could harm the livers of children who take it.

The move came after the regulator banned the Korean unit of Johnson & Johnson from selling the over-the-counter drug on Tuesday.

The regulator traced the problem to manufacturing flaws by Janssen Korea since May 2011 in which machinery failed to inject the proper amount of the active ingredient into the liquid and the process had to be done manually.

“It seemed that the machines couldn’t properly spray the acetaminophen. So the staff instead injected the substance,” said Jeon Se-hee, an officer at the Ministry of Food and Drug Safety in a phone call interview with the Korea JoongAng Daily.

The Seoul-based company said it began partial manual injections after equipment purchased in May 2011 showed signs of defects that resulted in large amounts of foam in the liquid product.

The manually-processed product is estimated to account for 8,000 to 9,600 bottles out of 1.6 million. About 3,000 have already been sold, according to the ministry.

The company is required to submit a recall plan within five days and finish the recall within 30 days from the day the order was issued.

The ministry launched an inspection on Tuesday after Janssen Korea reported the ingredient exceeded the standard found in children’s Tylenol on Monday.

There is speculation that the drug company was slow to identify the problem and some local reports raised questions over whether the company had shipped the product even after finding out the problem.

“It’s true that they first found the uneven amount of the active ingredient on March 18,” Jeon of the food and drug regulator said. “But it’s too early to say that the company sold the product after noticing the problem.”

Janssen Korea said it took the company a while to carry out an internal inspection into the issue.

By Park Eun-jee [ejpark@joongang.co.kr]