Qualitest Pharmaceuticals is voluntarily recalling several lots of birth control pills because of a packaging error that could leave women at risk for unplanned pregnancy, the U.S. Food and Drug Administration (FDA) said.
Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible, the FDA said in a statement on its website. The error means the daily regimen for the oral contraceptives may be incorrect and could leave women at risk of an unplanned pregnancy, it said. The defects do not pose any immediate health risks.
“This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots,” the agency said.
The recall takes effect immediately. It includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.
Guess whose mail-order pharmacy dispenses Qualitest and who has three packs that match the recalled batch numbers? Yours truly. I am extremely displeased but not panicking, since I always use condoms and have just started my period. But I called my pharmacist, who walked me through examining the packaging to see if what I had were the damaged packs with the pills out of order. Fortunately, they were not. And this is fortunate for Qualitest as well, because I am American and therefore not afraid of filing massive, multi-million dollar lawsuits. I could have bought the Harpy House for all of us a lot sooner than planned if dud BCPs had led to an unplanned Harpy fledgling.
So this is me, too. This morning I’ve called my regular pharmacy (who was very nice but told me they don’t issue Qualitest products), my doctor (who is closed for the weekend, so when I called the emergency number unkindly told me “birth control is not an emergency”), and Qualitest, repeatedly, who has a phone number that’s not working. (I sent them a scathing email, which I’m sure will do nothing.)
Mine are mail-order too, and yes, match the batch and lot number. I am freaking out, but it’s mostly because I am getting the distinct impression that the world just doesn’t give a fuck that thousands (millions?) of women are at risk here. Becky, you’re giving me hope that maybe my packs are okay. (I’m in a committed relationship and this is our only form of bc.)
On Monday, I now need to have a long call with my mail order express service — which I was anti anyway, but required to use it by my company — and have them replace (for free) my pills, because there’s no way in hell I’ll ever use a Qualitest product now.
I’m really just shocked at the lack of interest from seemingly everyone about what exactly those of us affected are supposed to do, you know?
Morkbee, did you call the mail-order pharmacy? Mine has a toll free 24 hour customer service hotline and they put me through to one of their pharmacists. She was really concise and helpful. I’m sure they’re getting tons of calls, so they knew how to respond. Also, I would punch out anyone who said “birth control is not an emergency.” it sure as hell is when it fails!
I have called multiple pharmacies and even (at their recommendation!) poison control – no one seems able to help me!
I google image searched the tri-previfem pack and my colors match up but Becky – any chance you can tell us what your pharmacist said regarding what color pill should be for week 1, 2 etc? That might give me some piece of mind.
thanks
Aha – thanks for the idea. Just got off the phone with them. The patient rep first tried to tell me just to call Qualitest (ha) but then passed me to a pharma. We went through the packaging, mine seem to be okay, but she recommended backup bc and that I call my doctor on Monday and switch to another brand.
Oy. Anyway, thanks for writing this — apart from the news stories yesterday that don’t say much, your post is the only helpful piece of advice I found!
@Kelly: Basically, the thing to look for on the pack I had (Cyclafem) was if the little foil bit on the back of the pack showed the number and expiration date (it did). On the defective packages, apparently, the foil bit is all jacked up and the numbers are unreadable. She also asked me to look at the pills to see that they were the right color and in the right place—mine go from white the first week to pink the second week then dark pink the third week and green for the fourth week. In the defective packages, the fourth week (the placebos that are when you have your period) are the ones that START the cycle, which is why it’s a serious problem. I don’t know what your pills normally look like, but that was one of the things the pharmacist asked—were the pills in the usual arrangement/color scheme or not?
morkbee,when you talk to your doctor, make your complain about the “birth control is not an emergency” thing. Not only is that completely untrue in some cases, it’s also lousy customer service and almost certainly not what your doctor whats from his/her emergency service. I’m probably spoiled because the only emergency line I ever call is the pediatrician’s and they treat parents with kid gloves, but I think that’s completely out of line.
Although, I did once have to call the vet’s emergency line because my new dog had eaten my birth control and I didn’t know if it would hurt her. They didn’t even put me on hold before they started laughing hysterically. That was also probably poor customer service, but significantly less offensive.
Birth control is not an emergency? WTF answering service?
When I read about the recall I felt like a punch in the stomach… millions of women possibly affected. Millions of women NOT affected but checking BC packaging and having anxiety, sitting on hold with pharmacies, etc. This should be a MAJOR news story, not just “another recall” type story.
Oy gevalt. Good luck to everyone affected.
Perhaps the person who doesn’t feel BC failure is an emergency would feel differently if, say, you got your attorney on the line. *scowls*
@kelly: i have triprevifem too. according to my package’s instructions, the white should be on top (week 1), and a light-greenish color is the placebo for week 4. if you look on the outside of the blue cardboard container it will tell you the correct color order.
Hello all! It’s nice to know I am not alone in this situation. Thank you for all your tips and information. Im taking tri-previfem too. I looked at the package and saw that the pills were according to the instructions and felt a little better. My pharmacist is close on the weekend and there was no way to contact them. I also called qualitest but i was on hold for 15 mins. I was shocked about this situation, but the fact that te colors match the instructions make me feel better but I still feel I can’t rely on it. Thanks for all the information posted
Well, “Birth control is not an emergency,” wins for “stupidest thing I’ve heard all day.” Fucking A.