Johnson & Johnson's ($JNJ) drug and product manufacturing problems just keep piling up. While most of them lately have been tied to over-the-counter products, the company is now recalling 32 million boxes of its Cilest birth-control pills because of solubility issues.
The voluntary recall does not include the U.S. but does affect 43 other countries, a spokeswoman tells Pharmalot. "The risk to women is considered to be very low as there is no impact on the safety or efficacy of the product," J&J said.
In recent weeks, the company has had to recall 3.3 million bottles of Tylenol Drops in Brazil because of a problem with the dropper that could lead to an overdose. It has also gotten itself crosswise with local regulators in India over a change in its baby powder sterilization process more than 5 years ago. J&J appealed that case to higher state authorities after the state FDA recently suspended its plant license for failing to report the change at the time.
The most serious matter is in South Korea, where authorities have launched a criminal investigation into problems at J&J's Janssen over-the-counter plant there. The probe means Kim Oak-yeon, CEO of the Johnson & Johnson subsidiary in South Korea, faces up to three years in jail if convicted. Authorities are focused on the fact that the Janssen unit continued to sell Children's Tylenol after discovering that manufacturing issues may have resulted in the products containing more than the labeled amounts of acetaminophen, a problem that can lead to liver damage. No adverse reactions were reported, and the company is working with authorities to resolve the issue.
This all, of course, harkens back to the serious problems J&J has dealt with at an OTC manufacturing plant in the U.S. that has cost it serious money and undercut its reputation with consumers. CFO Dominic Caruso recently said the OTC business in the U.S. is recovering nicely, with sales up 14% in the first quarter. But that came after several years of lost sales. 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. 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.
- here's the Pharmalot story