Sandoz recalls Introvale birth control pills over packaging error
08 Jun 2012
Swiss pharmaceutical major Novartis AG's unit Sandoz is recalling 10 lots of its generic Introvale birth control pills because of a packaging error.
The Introvale product contains 84 active pills that are peach coloured and 7 inactive pills that are taken in the 13th week are white.
Sandoz said that it decided on the recall after a consumer reported that white inactive tablets were mistakenly placed in the wrong row labelled week nine.
"While the white placebo tablets can be clearly distinguished from the peach-coloured active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," Sandoz said in a statement.
The US Food and Drug Administration (FDA) said the recall affects 10 lots distributed only in the US between January and May 2012.
"While the white placebo tablets can be clearly distinguished from the peach-coloured active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," the FDA said.