A new Johnson & Johnson manufacturing scandal – this one in South Korea – is worsening. Two weeks after the drugmaker was ordered to halt production of two types of Children’s Tylenol syrup because some bottles contained higher amounts of the active ingredient, regulators now plan to bring criminal charges against the Janssen unit there and ban production of five products over the next few months. And Jannsen Korea unit ceo Kim Oak-Yeon may face three years behind bars.
The Ministry of Food and Drug Safety had already ordered Janssen Korea to recall and discard nearly 1.7 million Children’s Tylenol bottles that were produced after May 2011, and now wants to hold the health care giant accountable for “producing and selling products that were a threat to public health.” The excess amounts of acetaminophen can potentially cause liver damage.
The regulator, meanwhile, also ordered production of Children’s Tylenol Suspension to be halted for five months. Similarly, production of Nizoral was banned for four months; and production of Ultracet tabs, another pain reliever; the Pariet 10mg acid reflux tabs and Concerta Oros ADHD 18mg tabs were banned for one month.
The production ban is not surprising. Earlier this month, a ministry spokesman noted that drugmakers are typically prohibited from producing medicines for several months when manufacturing problems are detected and, in this case, production was likely to be suspended for up to six months.
The problems purportedly began when Janssen employees manually placed Tylenol syrup into bottles as new automated facilities installed in May 2011 could not completely fill the bottles toward the end of the manufacturing process at the Hyang Nam facility, according to the Yon Hap News Agency.
“Despite being aware of the anomalies in March, it was a month before Janssen Korea notified us. During that period, the company sold about 38,000 bottles of Children’s Tylenol Suspension 100ml and 500ml, though they potentially could cause liver damage,” Lee Dong-hee, the ministry’s director, told a news conference, The Korea Times reports.
As we noted previously, this is only the latest manufacturing embarrassment for J&J. The health care giant is still trying to remediate a key plant in Fort Washington, Pennsylvania, where its McNeil Consumer Healthcare unit is headquartered, after the facility contributed to a spate of recalls. J&J (JNJ) consequently signed a consent decree with the FDA.
Ironically, J&J last month launched its first new corporate image campaign in more than a decade in hopes of restoring consumer confidence in its products after the huge laundry list of recalls – Tylenol; Motrin; Rolaids; Sudafed; Benadryl; syringes; K-Y Jelly; Accuvue contact lenses; hip replacement devices; and the Topamax epilepsy drug, among many others.
The campaign is also designed to deflect attention away from ongoing investigations and litigation surrounding a scandal over failure data for its hip replacement devices and marketing practices for promoting its Risperdal antipsychotic. In fact, a $2.2 billion settlement with the US Department of Justice is in the pipeline.
Kim Oak-Yeon, the Janssen Korea ceo, tells the news agency that the health care giant will use the latest incident as an occasion to make better medicines and improve quality control. "We will cooperate with the investigation by related authorities to try to regain the confidence of consumers, patients, medical professionals and the government," she said in a statement.
STORY ENDS HERE
jail pic thx to timpearce on flickr