Introvale Recall – The FDA (rightly) plays it safe

A birth control pill packaging error has led to a recall of Introvale, a 3 month birth control pill and generic for Seasonale. The apparent mix-up was that the placebo week was placed in the 9th instead of the 13th row of the pack.

Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. 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.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.

RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

The FDA is being appropriately cautious, and so should you. Follow their recommendation, especially if you have not been perfectly taking your pills. The pills are not what they should be, and they should be replaced.

But I have to admit, of all the pill packaging errors we’ve had to date, this one worries me the least. Here’s why – Traditional birth control pills have a placebo week once a month without impacting efficacy. So, unless the placebo week in the Introvate pack is one of the first 3 weeks of the pack, its placement elsewhere in the pack should do nothing more than give you an unexpected menstrual period. Certainly a placebo week that occurs after a full 8 weeks of active pills is not something that makes me concerned.

One exception would be a woman who had missed a pills or two just before that placebo week – not you’ve extended the pill free interval beyond 7 days and that’s a pregnancy risk. Which I suspect is one reason why the FDA is being extra cautious with their recommendations. I also suspect they’re making sure they’ve covered the possibility that there could be other issues with these lots.

What’s going on with birth control pill manufacturing these days?

I’ve never seen so many recalls – this is the third one in recent memory for me. All different manufacturers, all different pills. Anyone have any ideas?

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