June 5 Johnson & Johnson is voluntarily
recalling about 32 million packages of its birth control pill
Cilest in Europe, Asia and Latin America, a spokeswoman said
late on Tuesday, the latest in a string of recalls over the past
Cilest is manufactured by Janssen Pharmaceuticals Inc, a
unit of Johnson & Johnson. Spokeswoman Michelle Romano said the
recall of 179 batches was initiated because one active
ingredient in Cilest did not lead to a "defined specification"
in one routine internal test.
Media reports have said the tests showed one of the two
hormones in Cilest was being released more slowly than intended.
The pill is available in 43 countries, but is not sold in the
Cilest contains two hormones that are similar to the natural
hormones oestrogen and progesterone. Cilest, which women use to
avoid unwanted pregnancies, works by preventing the release of
eggs from the ovary.
The product remains safe and effective, Romano said, adding
that there is no risk for the women who had taken the pill. Less
than 800,000 individual consumer packets remain available for
sale, she said.
The recall, of which wholesalers and pharmacies were
notified in the week of May 27, involves pills that were
manufactured in or after 2011. The company did not issue a
formal press release announcing the recall.
"The recall is at the wholesale and pharmacy level and this
is not a patient level recall," Romano said.
In the past two years J&J has recalled over-the-counter
drugs, contact lenses, heart devices, and insulin pump
In March J&J's LifeScan unit recalled and replaced nearly 2
million meters used to measure blood glucose levels in diabetics
due to a failure to operate properly at extremely high glucose