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| White placebo pills should be in the Week 13 slot of Sandoz's Introvale--courtesy of the FDA |
Contraceptive packaging has become a hazard for drugmakers. Novartis' ($NVS) generic unit Sandoz is recalling 10 lots of a birth-control pill, Introvale, after finding the pills packaged in the wrong sequence. It's the third time this year that drugmakers have recalled mispackaged contraceptive pills.
Introvale is a three-month regimen of 84 active, peach-colored pills taken daily for 12 weeks, followed by 7 inactive pills for the 13th week. A consumer complained that inactive pills were for use in week 9, FDA says, prompting the recall. Taking birth-control pills out of order puts women at risk of pregnancy.
"While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," FDA said in a statement. If women find a white tablet in any position other than the 13th row, the agency said, they should immediately start using a non-hormonal contraceptive and call their doctors.
The warning is familiar: February 1, Pfizer ($PFE) pulled 14 batches of Lo-Ovral-28 pills and 14 batches of their generic equivalents, all made and packed by the company but marketed by Akrimax Rx. Some blister packs contained too many active tablets, while others contained too few. Then, February 27, Glenmark pulled 7 lots of generic birth-control pills because tablets were out of order in their blister packs.
- read the FDA statement
- see the Sandoz release
- get the story from Reuters