Birth Control Pill Recall Issued By Qualitest

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A packaging error that could resulted in unwanted pregnancies has led to a birth control pill recall by Qualitest Pharmaceuticals, impacting Cyclafem, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem. 

The birth control recall was announced by Qualitest, a division of Endo Pharmaceuticals, on September 15. The company reports that some of the pill-containing blister packages were rotated 180 degrees during packaging, reversing the weekly tablet orientation, which could lead women to take the pills in the wrong order.

If women follow the order of the birth control pills on the defective blisters, they may unknowingly be without contraceptive protection and could be at risk for unintended pregnancy. In addition, the defective blisters do not show the expiration date or the lot number. However, there are no other health risks associated with the recalled birth control pills.

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Qualitest recommends that any woman who took pills with the defective packaging immediately begin using non-hormonal forms of birth control and consult their health care provider.

The recall affects more than 70 lots of various Qualitest birth control pills, including Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem. A full list of lot numbers affected by the recall is available here (pdf).

This is the second packaging recall Qualitest has had to conduct this summer and the third packaging mistake recall for the company this year. In June, a manufacturing problem led to labels being swapped between bottles of generic Vicodin and Fioricet. On February 5, 2011, three lots of generic Vicodin and Phenobarbital were recalled after a bottle of Vicodin was found with a Phenobarbital label.

Pharmacies have been instructed to alert women who were given the pills about the recall. Consumers, pharmacists or physicians with questions or who have a product to return can call Qualitest at 1-877-300-6153.


64 Comments


Tammy
My teenage daughter was on Tri-Previfem she went and got one of her refills March 1, 2014. March 14 of 2014 she turned 19 years old. April 1 of 2014 she passed away from a massive pulmonary embolism covered the entire right side of her heart.

Jamie
I was prescribed Microgestin and diagnosed with antiphiphoslipid antibodies (blood clotting disease), and ischemic stroke. Those are all strange but have medical proof for these things

latoya
i started taking tri-previfem in april 2016 and the doctor knew I was a smoker, to shrink a cyst. one month and a half into taking pills and had stroke at the brain due to a blood clot.

Helen
I was taking loestrin fe 1.5/20 from my gyno, then when I went to get it from the pharmacist they gave me gildess fe 1.5/20 (the generic form of loestrin). I got pregnant in may 2011. I now have a 3 1/2 year old son. I had no idea that it was recalled or that this was even happening!

Sarah
My mail order pharmacy started sending me Gildess FE 1.5/30 instead of the Microgestin FE 1.5/30 that I had been taking for years. What terrible side effects I suffered with Gildess!! Headaches, bloating/weight gain, depression… this stuff is TERRIBLE! Now I’m on Junel FE 1.5/30, & I feel so much better!

erisha
I was taking emoquette n almost lost my life bilateral pulmonary embolism. I am currently out of work. I have to use an inhaler now. Please take this off the market.

Jamie
I wouldn’t recommend MonoNessa To Anyone its too life Threatening!

Kim
I to a completely healthy person at the time used “Sprintec 28” and suffered “Pulmonary Embolism” in both my lungs. I was out from work for a few months.

Joelle
I was recently switched to Tri Previfem after using a different generic for about 5 years. I never once had any kind of problem on the previous generic. I have only taken one pill so far, but am already experiencing some of the side effects. Maybe this is just coincidence,but it still kind of concerns me. After reading a bunch of previous posts and some more current posts, I am afraid to continue using this medication. Especially after hearing about the recall, which happened less than 2 years ago and it still sounds like a lot of the issues are the same and then the lawsuit. I don’t. Understand why it is even still on the market, however, I don’t know how all of that stuff works.

Karen
I was using Tri-Previfem for only about a year. I do not smoke. I was recently diagnosed with DVT and Pulmonary Thrombosis. That is blood clots in my leg and my lungs! Doctors said it is a direct result of using these birth control pills. I almost died!! If you know anyone using these pills, tell them to stop before it’s too late. I am looking into a lawsuit.

Tawana
I started taking Springtec last year. After 2 months of being on this pill I was hospitalized with a pulmonary embolism. Every since then my blood count has been off, i hve been having long and clotty cycles, I have to take blood thinners for the rest of my life and my chances for my husband and I to hve a child is not looking to bright

Tammy
My daughter was on Mononessa birth control, she had a stroke on it. I will never again let her on any birth control period. I think they should find a better way of protecting our children.

Melissa
I was given this pill at the pharmacy due them saying that is was a generic for the original pill that I was taking. And then I came out pregnant and then miscarried about 2 months later, i due believe that my miscarriage was due to pills but I had no idea about this. My doctor told me that it was due to me being over 40 and diabetic may have been the cause of the miscarriages but I don’t think that she knew of the recall and if this was truly the reason for my miscarriage and I went throught alot due to this miscarriage. My smallest child was already 14 and this was very heartbroken for me and painful.

Evelin
I thought something had gone wrong my daughter has been on this pill for 1 year when she had double periods. She is not sexually active I think. My gosh what a life destroying situation if she was having sex. I phoned the doctors and asked she said it was a bad batch of pills then blewit off. Couldn’t believe the lack of care. Bit if men got pregnant this issue would be front news. May as well go burn my bra cause no longer are we treated equally. No one gives a dam that they screwed up. Would be nice of they said SORRY

carrie
well i did get pregnant last july i’m quite sure as a result of this, having taken same type of pill for 22 yrs and never got pregnant. and it was pure hell. i take psychiatric meds which made this a horrific decision for me. I’m having a hard time with getting info from the community clinic {where i received mostly free care} who gave them to me. they won’t give me a lot number or other info to follow up on, treating me like i’m nuts to want this info. if there’s a lawsuit i want to be a part of it no one ever contacted me about this, it has caused me so much grief and pain and guilt. i can’t seem to find any help on confirming this terrible error that i have to live with. i don’t know if i can even handle finding out, the fight would probably push me further over the edge of…losing any coping skills i have left

ashley
i had been on a generic yaz pill for well over six months and never missed my pill, then one day in october thinking i have the flue i go to the doctor only to find out im pregant. How is that possible? then some one mentions to me that theres alot of faulty birthcontrol that was sent out around the time i concieved my unborn son. id like to know what i can do to get answers and action going agains the birthcontrol company i was on. i paid for my birthcontrol to prevent pregnacy not to help me get pregnant.

anna
Im worried. Has this issue been resolved ?? I just started tri previfem about 2 weeks ago …..

Susan
My 19 daughter had switched birthcontrol pills in December 2010 because of the $50 co-pay. She was put on Gildess fe 1/20. In March 2011, she DIED. The only thing they could associate her death to was the use of ORAL CONTRACEPTIVES. She was very healthy and physically fit otherwise. I have checked her packaging and her’s is on the recall list. I am thinking that the excessive hormones caused the stoke that killed her. Is there anyone interested in taking this case on?

Jill
I took my BC religiously for years. I recently had a baby… I am a single mother, had a terrible pregnancy (bedrest for 4 months), and my child may have a minor form of Spina Bifida. Reading all of these comment, these companies need to be held responsible for this. It’s not like these companies don’t have the money…

Stefanie
I was wondering how I ended up pregnant recently after being on the same pill for 6 years with no problems….this happened as a result to someone not doing their job….I checked lot numbers and expiration dates and mine were of those affected. Is anyone going to have to pay for this!?

Nikki
I am not taking this particular medication but am on Tri sprintec. I take my pill daily at the exact same time and have just recently discovered I have gotten pregnant while taking the pill. So far no recalls on this one but I am beginning to wonder how effective it really is. Being a person who follows the instructions and have taken it for a year I should not be pregnant but right now but here I am.

Theresa
I had been on Tri-Previfem, and stopped taking them. It’s now been 4 months, no cycle, hot flashes, etc. I’ve been to the doctor, and I’m not pregnant. Has anyone had this problem of not starting a cycle when trying to conceive?

Kim
Carole, Have you filed your law suit or hired an attorney yet? Many of us will be represented by Keith Bodoh (Bodoh@RBNlaw.com). Your family is in our prayers as we know exactly what you are going through. Dee, Are the gall stones a result of the birth control pills and is there a connection with the packaging error? Either way, you shouldn’t be in pain like that at your young age. Gall bladder surgery is a very simple non-evasive surgical procedure nowadays (out-patient w/fast recovery), but you need to have it taken care of before it creates many other issues. Good luck to you and hope you feel better soon.

Dee
I used it for a few months and now I have Gaul stones at the age 22 it hurts like heck and I need to do something about it soon. Anyone know what I should do right now

Carole
My 19 year old daughter found out she was pregnant days after getting the recall letter from the pharmacy. She is a full time college student who now been forced to change her plans for the whole rest of her life because of this mistake. We will be filing a lawsuit.

Kim
My daughter was prescribed and taking the Previfem at the time of the recall. Unfortunately, the recall was not issued in time to prevent an unintended pregnancy. She only turned 19 in August & is a full-time college student who lives at home. At the time of the pregnancy discovery, she was being seen for dysplasia & possible HPV cells that were discovered through her annual check-up on August 25th. Scheduling of a Colposcopy and/or cervical biopsy would be performed upon the receipt of authorization from the medical insurance provider. Some serious decisions had to be made for health reasons and her Nov. 2nd biopsy confirmed our fears. She will be having surgery in two weeks to remove the cancer cells. Prior to the recall, she had many of the above described symptoms (bleeding, cramping, moods, sickness) leading to trips to the emergency room. In addition, she was diagnosed & treated for GBS disease as a result. We have contacted Endo and WILL be filing a law suit!

Laura
i was on this pill and received a letter Nov 2nd that they were recalled so i made a Dr app and got pregnancy test and it was positive. Now i have no idea how far i am. I haven’t had a cycle for 3 months which is normal for me. I am so upset and freaking out. Cannot believe this happened.

Pamela
Lynn- Go f**k yourself. I was switched to a defective birth control and became pregnant while using the product. The middle name comment was a joke, but it seems like you are probably to stupid to pick up on that. I’ll let it slide this time….

Lynn
‘—“Comment by Pamela on 27 September 2011: I have been on birth control for almost 8 years. My insurance company recently switched me to Tri Prevefem and after being on it for roughly 2 months I’m 18 weeks pregnant. My husband and I are thinking about naming the baby’s middle name “Recall Tri Prevefem”…………” Pamela, I’m curious how you’re 18 weeks pregnant “roughly 2 months” (roughly that’s 8 weeks) after a birth control failure. Hopefully you’ll exercise a little more thought in the future. (I would start with your future child’s middle name, unless you want them to be a constant reminder of your complete lack of logic)

Suzanne
I too was informed of my “faulty” birth control pills and have not had a period since August….. I am thinking that I might be prenant at this time and I am 44 years old and not wanting a child right now!!! I will absolutely sue someone if I am pregnant…. this can’t be happening!!!!

Brittni
I was on Tri-Previfem and had tons of issues with irregular periods. One instance of which I bled HEAVILY and WITH GREAT PAIN for a month and a half. Now I know why. If anyone has any information of class action suits against them, please contact me.

Becky
This is appalling. Though I am not pregnant, while on the messed up pack, my face broke out terribly. And I used to have flawless skin. I also had terrible mood swings. These poor women that turned up pregnant because of this—I say Qualitest should pay for each kid’s college tuition.

Jennifer
I was taking tri-previfem and got the recall letter and by then I was already pregnant! I am so mad because this will be my 3rd child. I was not planning on another one and can’t afford it. I am going to use Keith Bodah to represent me. This is so irriatatating. =(

Tiffany
I am taking the Tri- Previfem and just got off the phone with the pharmacist. She said that even if your Lot # was recalled as long as the expiration date is visible that your birth control packs are not suppose to be affected. I really hope this is 100% true and maybe this will ease some of your minds.

Kelly
I just found out about the recall. I have been taking gildess fe 1/20 since January of this year. Within the past 2 months I have had heavy bleeding lasting close to 5 weeks. I have also had severe depression, horrible breakouts, extreme anxiety, vomitting, constant spotting, increased agression, and headaches. All along I have been blaming stress. Both the gildess I took last month and the one I took this month were on the recall list. My pharmacy never contacted me, and it has now been almost a month since the recall. I guess I need to go buy a pregnancy test now. The FDA needs to dig deeper into this recall because obviosuly there is more wrong than just a packaging error.

Aconcerned woman
I have been on gildess fe 1/20 for the last five months and have had excessive bleeding, mood swings, depression, and nausea. If there is a lawsuit, Ill be the first to sign up. Seriously I am going to sue them for every penny they have for making me suffer and for increasing the chances of pregnancy. What kind of fake comapny is this?

LR
I can’t believe this either. I received a letter about the recall from my pharmacy on 10/6 my sons FIRST birthday. Then i started panicking because my period was late, the next day I took a pregancy test and BOOM… Looks like i’m pregnant again… I did find some info on a class action lawsuite online i’m not sure how legit it is but it’s worth checking out…I can’t remember the website but the attorneys names are Keith Bodoh and Steve Beard. Ya’ll should google them and see if it is valid.

Angie
I just found out that my package is one of the ones affected by this mix up. These people do not know how serious this is. I am on birth control for a reason. I had cervical cancer removed twice in the past 2 years and during my 1st pregnancy me and my baby both nearly died. I am very worried because if I am pregnant our lives could be in danger. This really upsets me because I understand that mistakes happen but this big and 3 times in 1 year! That is beyond horrible!

LH
My pharmacy called me and told me to discontinue my use of the gildess fe 1/20 that it had been recalled. WOW. That explians it. Im 25 I had a set of twins last Nov. on top of the two children that my husband and I have. I thought I was safe taking my pills religiously. I was on the higher doseage and it kept me sick so about 5 months ago they put me on this, My periods wouldnt even out, so i contacted my obgyn and they said it could be where it was a lower dosage, or that I could have an infection. neither was the case. The day before the pharmacy called me my husband and I did what spouses do (worrying about having a baby WAS the last thing that was on my mind) when we recieved the call and were told to use a back up methood, we sure did NOT DOING IT AT ALL! They also wanted me to bring the unfinished pack in. I still have my unfinished pack. I called my ob and they called me in a different script and I went to pick it up and it was through the same company so they didnt send it. I went to my ob and she gave me the nuva ring and said the first day of my period place it,,, WELL Its been a month since that call, and for my sex life for that matter & I am offically LATE for my period by my calculations. My question is if I am pregnant again lord help me What is ths company going to do about it, thier mistake could very well lead to another life for me and & what about the lives that are now “in the ovens” because of thier mistake?? And if im not what can you do with a company that has caused all this stress and worry in my life?? My hormones are off the chart crazy, My husband and I have have had some pretty intense fighting from my hormonal imbalance all due to the fact of “WHAT IF”.

JB
I am going through the SAME thing you all are. CONTINUOUS Spot bleeding, cramps, vomiting, diarrhea, depression, moodyness, etc. Has felt like PMS but EXTREME for a month. I have been on previfem for awhile. I am on other medication I am UNABLE to have a child while on and HAVE to have my birth control work correctly while on it. Guess I should take a pregnancy test too then because at this rate who knows! This is UNACCEPTABLE from a company of this size and importance. I read on CNN that they have had 3 RECALLS this year. This is completely crazy! How many of us are there?

Tracy
I also just found out about this. My husband and I use two forms of birth control in case one doesn’t work for whatever reason, that we can be protected. I don’t know how long this is going on but I got my period two weeks ago. I did notice that this months pack was packaged wrong, so I’ve gone a week with pills not working (still used condoms though). I’m trying to figure out how much I should be worried.

Aimee
I have one of the affected packs.. In my case, If i was to get pregnant I can die. I have a disease that puts my life & the babies at HIGH risk. This is unbelievable. I Pray to God I am not pregnant. I was taking Tri-Previfem.. All those others out there could have the same issue as me.

Pamela
Lauren, I was told the same thing at first, but it is not true. The pharmacist tried to say the same thing to me, then turned my case over to “quality control” and I receive a call back the following day saying that my birth control was indeed defective, which I already knew. I’m no pharmacist, but I have been on birth control for 8 years with no issues and suddenly after taking Tri Previfem that is on the recall list I am pregnant. If you are not already pregnant just be cautious……

mickie
My daughter, who is typically very confident, happy and full of life, had been on a recalled gildess fe 1/20 for two months. She is a junior away at college. She became depressed, started experiencing extreem anxiety and panic attacks. She would cry unconsolably and started having irrational thoughts about herself, her dicisions and relationships. she has lost nearly 15 pounds has nausia and horrible acne. She started seeing a therapist who suggested that the BC could be the cause. Two days later her BC was recalled for “packaging error”. I googled this BC and found many, many, many women experiencing the same side effects from this drug and all within the last year. I am telling you there is more wrong with this BC than the packaging. I want my daughter back and she wants her life back. Lawsuit? You bet!

Lauren
I spoke with my pharmacy, and they advised me if I could see the lot# and expiration date through the windown on the back of the packaging then I was safe to still take the birth control (even though it was on the recall list). Has anyone else heard of this??

Pamela
I have been on birth control for almost 8 years. My insurance company recently switched me to Tri Prevefem and after being on it for roughly 2 months I’m 18 weeks pregnant. My husband and I are thinking about naming the baby’s middle name “Recall Tri Prevefem”…………

Sandy
My daughter is a senior in high school and is now 18 weeks pregnant. She has been taking Previfem, her packages were on the defect list, this is an outrage. I thought birth control was exactly that…BIRTH CONTROL. When using 2 birth control methods, you would think one of them would prevent you from getting pregnant. This company should be shut down. I want to know any possible info regarding a lawsuit against this company.

janie
I just found out about the recall. I also just found out that i’m pregnant! im a student teacher and ready to graduate this may. now it looks like im due end of april or begining of may!!! i have no insurance so i feel lost!!! i dont know what to do!!!! i was not wanting to have another baby. Im worried about the birthcontrol pills i been taking will hurt the baby! i didnt know i was pregnant!!!

Laura
this is absolutely criminal. I am 42 years old and having a baby would be inconceivable…hence the reason for taking the pill. I have spoken with my pharmacist and with the company and the best they can tell me is that i should take a pregnancy test before resuming the use of birth control. Wow thanks for the help! At 42 i have a 1 in 60 chance of having a baby with downs syndrome…….this is just WRONG

Maggie
I called my insurance company monday when I learned about this after returning home from a honeymoon. They told me to call the manufacturer. The manufactuerer was closed when I called, so they called me back a day and half later, and their advice was to call back my insurance company and have them replaced. I just called my insurance company who told me that the pill is on backorder so I would need to visit a pharmacy and have them replaced. I asked if I was to pay for another prescription and they said yes, I would need to pay. Are you serious! I then prompted as to why I would pay for such a screw up and they put me on hold and came back to the phone and told me to call back next week and see what the status is. I said it’s recalled, and they told me they had not received any information about it being recalled. Are we serious people, I am very careful about taking this medication and now you tell me I’m more at risk than not having taken them!

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