Just this month, Johnson & Johnson ($JNJ) had to recall 200,000 bottles of its concentrated Motrin infants' drops after plastic particles were detected in the API and 5,000 vials of its antipsychotic pill Risperdal Consta because of mold. In June it recalled 32 million boxes of its Cilest birth control pills because of solubility issues. But in one positive turn, the company is being allowed to restart production at a baby powder plant in Mumbai, India, that was closed by regulators in June.
The company ran into trouble with state health authorities when it was learned that years earlier it had released 15 batches of baby powder that had been sterilized with the potential carcinogen ethylene oxide but had not been checked for its residue. Officials closed the plant on the news but J&J appealed the order. The company said there were no consumer complaints or adverse events reported and that it later tested three batches of the powder and found nothing of concern.
A Bombay high court last week overruled the order from the Maharashtra Food and Drug Administration that had yanked J&J's license for the plant, The Times of India reports. The court sent the issue back to the FDA with the judges asking who would compensate them for the closure if they won their legal challenge. About 250 people work at the facility.
It is one positive note in what has been a tough year for its manufacturing side. In addition to the recalls of Motrin, Risperdal Consta and Cilest, in May regulators in South Korea launched a probe after J&J's Janssen unit released some Children's Tylenol products that contained excessive levels of acetaminophen, then reportedly waited a month to acknowledge the mistake. Overdoses of acetaminophen can lead to health issues, even fatalities.
The issues are not new for J&J, however. Its McNeil Consumer Healthcare unit signed a consent decree with the FDA in 2011 promising to get on top of quality issues after years of recalls tied to problems at its OTC plant in Fort Washington, PA. It has spent $100 million to upgrade the facility after having to recall tens of millions of consumer products, including Tylenol and Motrin products, because of quality issues.
- read the Times of India story