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


Sondy
This is a disaster! I’ve had headaches, dizziness, diarrhea, horrible cramps, and excessive bleeding for 3 weeks. And I have only been on it for 2 months! This company is crap. On top of that I have yet to receive any information about the recall. And it was only when I told my pharmacist about my symptoms that I was told about the situation and that was today! I’m extremely upset. What if they actually put something else in the tablets? How about if there are long term affects? I’ve been on many different birth control pills and I’ve never had this happen. They should be shut down.

Brandi
Geesh! This is absolutely poor judgment! I take Tri-Previfem for a reason! I smell lawsuit. In addition, my pharmacy is at fault because as SOON as they found out they should have notified every recipient of the faulty birth control pills.

Brittany
I have been taking gildess fe 1.5/30 for over 2 years now and when the manufacturer changed about 5 months ago I have not had a period since. I have been to the dr twice and emergency room for pains. Now this explains the discomfort I’ve been in and mood swings sweating and hormonal problems. my dr couldn’t explain whet was wrong bc she was not aware of this mix up so I’ve been thinking something is serious wrong that can’t be detected!!! This had been a huge mess!

Gwen
I have taken Tri-Previfem to prevent ovarian cysts and for two years it worked. In August I had to have surgery to remove a 8cm cyst along the ovary and fallopian tube. I would definitely like to sue this company for the misery and pain caused.

Ed
My daughter just had a baby. My wife and I were giving her a hard time about missing taking her birth control pill. She swore she never missed taking the medication, she kept saying birth control is only 99.9% effective. Come to find out she was on Gildess for the last year. Is there a class action in work? My daughter is finishing college and the baby was definitely not planned.

Tess
I never had high blood pressure or sweat or had various limp noids swell up and the list goes on before I had a c-section for my son on 12/11/2009 and low and behold all these weird health issues r here after I have him I’ve been on low ester-c gilldess birth control for about a year and a half ,,,,,, Im wondering if it’s from the birth control that just got recalled?????

Shannon
I have been on Tri-Previfem for years, and over the past year, I’ve dealt with numerous issues involving irregular cycles (when I’ve always been regular to the hour of the day of when my cycle should begin). All of my packages of pills are listed on the released recall list. My menstrual issues may be due to the fact that I’ve been taking a row of inactive (sugar) pills, followed by only 2 weeks of active pills, and then throwing away my final row of what should have been inactive (sugar) pills but were actually active pills! If there is going to be a class action suit against Qualitest for this huge recall of birth control pills, can you please let me know? I’ve had numerous issues over the past year, including the need for a pelvic ultrasound after a menstrual cycle lasting nearly 16 days. Now, my birth control prescription has been canceled by my pharmacy, and I’m in the process of trying to find a new prescription and having it filled before I need to start my next set of pills. This has become an impossible, and expensive, mess! Pelvic ultrasounds are not cheap! The number listed for Qualitest takes you to a representative who collects your contact info, gives you a reference number, and tells you to contact your pharmacy and doctor (no additional information is provided). My pharmacy couldn’t help at all and told me to contact Qualitest or my doctor. My doctor is not available. I’m glad to see Qualitest considers this to be a “voluntary” recall that has caused “no immediate health issues”…I beg to differ!

Laura
I have been having irregular periods (plural!) this month after being on this RX for over a year. I have NEVER had irregularity before I checked and saw that my batch was affected. Now I know why.

Tobi
SO I have taken 3 test and they are all positive. This is after taking Tri-Previfem, and you better believe I’m lawyering up. They will be responsible.

Joseph
I just had a child 8 months ago and recently found out we were pregnant about two weeks ago. The day the recall was announced she was at the doctor getting it confimed. If there is an actual class action aginst this please inform me.

Monalisa
Wow, I have been on this for the last Year and a half, I guess this explains why I am pregnant….. wow, I would have liked to have known earlier……

nat
Can we sue this company, qualitest for their negligence? This is one major screw up. violation of consumer trust.

Kait
so mad about this. I take birth control for a reason, I shouldn’t have to worry about packages an pills getting “mixed up”.

Catherine
This is a horrible and uncalled for mistake. I will never use this company again. It sounds like they make many errors. They should be shut down. Luckily my re-call is not life threatening.

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