06 Jun 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Johnson & Johnson (J&J) has recalled more than 32 million boxes of its Cilest birth control pill in 43 countries because the active ingredient dissolves too slowly and decreases the contraceptive effect.
Although the risk to women because of the contraceptive is considered to be very low (as there is no impact on the safety or efficacy of the product), J&J is withdrawing the drug as a voluntary preventive measure.
The recall is just one among several such moves made by the firm in the past few weeks. In Brazil, more than 3.3 million bottles of Tylenol Drops were pulled because the dripper malfunctioned and could cause an overdose (back story).
An insulin pump was recalled over false alarms that could prompt patients to unnecessarily reach for insulin. Some 2.3 million packages of K-Y Jelly were recalled because of product changes that required new regulatory submissions (see this).
J&J image has been hindered over the past three years by several manufacturing ills. These have not only led to a consent decree with the US FDA but also forced the firm to make managerial changes, prompted shareholder lawsuits and sparked Congressional investigations.