Birth Control Pill Packaging Error Leads to Recall – Tell Someone

CLICK HERE FOR INFORMATION ON THE FEB 1, 2012 PFIZER BIRTH CONTROL PILL RECALL.

A recall has been issued for certain brands of generic birth control pills. The pills have been recalled because they were packaged incorrectly, which could lead to unplanned pregnancies. Essentially, the pills were packaged upside down. This could lead women to take an extra week of placebos at the beginning, rather than the end of the pack, leaving them unprotected against pregnancy.

Brands affected are –

  • Cyclafem(TM) 7/7/7
  • Cyclafem(TM) 1/35
  • Emoquette(TM)
  • Gildess® FE 1.5/30
  • Gildess® FE 1/20
  • Orsythia(TM)
  • Previfem ®
  • Tri-Previfem®

What should you do if you’re taking a recalled pack?

If you’re taking one of these brands, don’t panic. First check to see if you are taking an affected lot by going to http://www.qualitestrx.com/pdf/OCRecall.pdf. Your pill’s lot number should be on your pill card or pack. A tip off that you have an affected pack is that the seven days of placebos, which are a week of different colored pills than the rest of the pack, are at the beginning of the pack. Pill users can call 1-877-300-6153 between 8 a.m. and 5 p.m. CT for further information. You can also head to your pharmacist for help.

Talk to your doctor about what you should do if you are taking a recalled pack.

Here’s what I’ll be telling my affected patients. (Disclaimer – what follows is information about advice I will be giving my patients. What your doctor may want you to do could differ. Talk to your doctor if you are taking an affected lot of pills )

  • If you’re taking a recalled lot of pills, head immediately to the pharmacy for a new pack.
  • If you’ve been sexually active since your last period, do a pregnancy test. If it’s negative (and it most likely will be negative), start your new pack immediately and use condoms for the next two weeks. Your next period should come at the end of your new pack of pills. If it does not, do another pregnancy test. If you don’t want to wait till then to be sure you’re not pregnant, you can do a second pregnancy test two to three weeks after the first.
  • If you haven’t been sexually active, no harm has been done. Get a new pack and start it right away. Use condoms if you have sex in the next two weeks.
  • If you’re pregnant, contact me. What you decide is up to you, but know that accidental exposure to normal doses of birth control pills in early pregnancy should not impact the pregnancy outcome.

I expect a message from my EMR very soon giving me a list of those patients known to be taking these brands so I can contact them personally. But most of the time, I have no idea which generics my patients have been given until they come back next year for their annual or call for a refill. But the pharmacy and their insurer know which pills my patients are taking. Hopefully their databases are kicking into gear to rapidly identify and contact affected pill users. The lawyers are probably kicking into gear even faster…

Last updated 10/23/12

13 Responses to Birth Control Pill Packaging Error Leads to Recall – Tell Someone

    • If you knew which pill was which, you could. But I don’t know enough about each brand’s packaging error to say, and every pill has different colors. Most placebos are green. Easiest and safest, in my mind, to just return the pill for a new pack. If you can’t get to the pharmacy, use backup condoms and take what looks like an active pill would be what I’d tell my patient who asked the same thing. But I’d be sure to ask which brand they are taking and look up the placebo color (should be green, but I have not looked at each brand’s package insert to be sure) before I gave that advice.

      Reply

  4. Awesome. So glad I don’t use BCPs.

    My health insurance plan doesn’t cover any care related to pregnancy, including abortion of unintended pregnancies. Hypothetically speaking, are the pharmaceutical companies with the faulty pills planning to pay non-covered medical expenses for people with crappy individual plans like this?

    Reply

  5. I got a call from my pharmacy on a Friday night about this. I had a possibly affected pack. My doctor asked me some questions about what was going on. Told me to finish my pack (since I was in the last week) and start a new one. I’m still really nervous. A test will be done soon.

    I like that you mention the colored pills being at the top of the pack (in cases when there are color differences). I wondered about that. Mine looked the same as they always do. So..there’s hope, right? ha.

    I’m curious to see what happens re: law suits, etc.

    I’ve been considering switching methods of birth control for a while now. This is really helpful motivation!

    Reply

    • I actually called the pharmacy this morning and they just said the packaging was upside down, but the pills that were colored active and placebo were still the same (as in active = white, placebo = brown). I never actually looked at the weeks and took it based off the 3 weeks of one color and the last week of a different color. The pharmacy said that if you did this, it would be fine.

      Reply

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