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Glenmark Generics is issuing a nationwide recall of seven lots of birth control pills. The pills are labeled "norgestimate and ethinyl estradiol tablets."
Because of a packaging error, some of the pills were placed in the wrong order within the packs, according to a statement from the Food and Drug Administration. The packs contain three types of pills with varying levels of hormones, designed to be taken at different times during a woman's cycle.
The pills were rotated 180 degrees within the pack, so the weekly tablet orientation is reversed, and the lot number and expiration date are visible only on the outer pouch, according to the FDA. Any pack for which the lot number and expiry date is not visible is subject to recall.
Because of this error, the daily regimen for these oral contraceptives may be incorrect, leaving women without adequate contraception, and at risk for unintended pregnancy.
These packaging defects do not pose any immediate health risks, but consumers whose pills are affected should begin using a non-hormonal form of contraception immediately, the FDA said. Patients who have the products(lot numbers are provided below) should notify their physician and return the product to the pharmacy.
Lot numbers of affected packs are as follows: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. The packs were distributed nationwide between Sept. 21 and Dec. 30, 2011. The complete name of the product is norgestimate and ethinyl estradiol tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic).
The error was discovered when a consumer complained she received a pack in which the tablets were packaged in reverse order, the FDA said.
In the correct packaging configuration, the top row contains seven white to off-white tablets, and the bottom row contains seven inactive, light green tablets in bottom row ( correctly packaged packs are pictured here ).
Last month, Pfizer recalled 28 lots of generic birth control pills labeled Norgestrel and Ethinyl Estradiol tablets, when the company found some packs contained an inexact count of inert or active ingredient tablets, and tablets out of sequence.
More information is available on the FDA's website.
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I wonder if these are really "accidental" errors?
No, they don't have those kinds of "accidents" in Mumbai, India, headquarters of Glenmark Generics Pharmaceuticals.
Lois, my thoughts exactly.
persons in the pharmaceutical industry are sabotaging drugs that affect millions because of their personal beliefs? Well, get over it and join the push to make industrial sabotage of any type of drug a capital offense.
AYUT--but in the mean time, Women are getting Pregnant from this mistake!!! This is SABOTAGE by someone on the inside who hates Women for Pro Choice reasons. Funny how these things happen when the Country starts talking Birth Control, Catholic Nuts running around. Rick Santorum enjoying himself.
Baby boom in 9 months.
Or a rash of abortion pill prescriptions being filled in the next 6 weeks.
They will probably sabotage those too....Damn closed minded freaks!!
A T-bagger has infiltrated the corporation that produces these birth control pills!
Whoops. They did it again.
Whoops they did it again.
Seriously??? I mean REALLY?!? Come on! Again? Are you people TRYING to get me knocked up? wtf man.
Does this apply to Ortho tri cyclen pills? This article didn't really say WHO is recalling!!
i know.i was thinking the same.i use ortho tri cyclen
The article clearly says Glenmark Generics. Perhaps someone should re-read the article?
It says Glenmark in the article. I use the generic form of Ortho Tricyclen and yes, it is what is recalled if you use the generic form of Ortho Tricyclen distributed by Glenmark. My pill packs are in the lot numbers recalled, but the pills are all in the right order. That doesn't really ease my mind though.
Your pharmacist would call you and tell you your pills are recalled if it were the case.
Is that the name labeled on the package or is it marked with a name for that particular type of pill? Like Yaz has a generic named Gianvi. I wouldn't know who manufactures Gianvi off hand without looking it up.
Careful! Your pharmacist will not necessarily call you. Mine did not and I did not find out my entire pack was recalled until after I had completed taking it. There are different levels of recalls and when the reason for recalling does not endanger your life (like in this case) they will not call you.
ThaKhanKubla
This has NOTHING to do with politics. Just incompetant manufacturers. Nothing more, nothing less. So please, stop trying to cause drama.
But they're "free" now............ You get what you pay for.
If all else fails, hold the packaging between your knees.
Free or not this shouldn't be happening.
I pay $160 a year for mine. Wish I knew where to get them for free.
Mine have never been "free".
Thank people for being responsible enough to take birth control instead of having 13 babies and leaving tax payers to pay for them.
Oh wait, I guess married people and unmarried couples shouldn't be allowed to enjoy eachother without popping out babies, should they?
Additionally, they aren't JUST for preventing unwanted pregnancy. If I didn't take my birth control I'd be out of work 2-3 days each month due to incredibly painful cramping.
seatackle-great post. i completely agree with you!
I see a class action coming in a few months.
Just "reverse" the package...problem solved.
Uh I wouldn't trust that the individual ones were in the correct order even if it were reversed.
persons in the pharmaceutical industry are sabotaging drugs that affect millions because of their personal beliefs? Well, get over it and join the push to make industrial sabotage of any type of drug a capital offense.
I hope you're being sarcastic, but in case you're not, it was probably an error in part of the person who lays the blister pack onto the card on the production line.
Seriously, we've been following the same recipe for years and suddenly we can't seem to make a batch right to save our lives. I personally don't use birth control pills but, I have no problem with anyone choosing to use this as a form of birth control if they wise. I think some investigation is in order at this point.
GForce77, its not the "content" of the pills that are being recalled, its the packaging that is.
Personally, even if a product is packaged correctly, dont you people inspect what you consume? I would hope that most women are smart enough to realize that the pills they take are backwards. I think thats why they are color coded for a reason?
Why I love NFP :)
Celibacy is even easier, but less fun :(
This is exactly why I use Natural Family Planning...I dont trust Birth controll.
In reading about side effects of birth control pills, generally, I think I would think more than twice about using them. There is hightened risks for breast, liver and cervical cancers, heart attack, stroke, and blood clots.
A lot of that is if you're a smoker. Also, the risks are minimal. I know a bazillion people who take birth control and I haven't heard of any who have experienced any of that.
Possibly side effect of not taking birth control: having a child.
Everything carries side effects. Three-quarters of the foods that the majority of us consume have ingredients that are linked to those things (and others).
Let me rephrase that a little because I don't eat many foods that I've heard cause "cervical cancer". Perhaps not those diseases in particular, but there are plenty that have been linked to cancer, heart disease and so on.
Everything carries a risk of cancer. I swear.
Gail, outside of what seatackle said about those risks being elevated mostly in smokers, they are also elevated if it is a higher dose estrogen pill. Low-dose estrogen pills have been linked to reducing the risk of endometrial cancer (the most common gynecological cancer) and ovarian cancer. Yes, there needs to be a balance of risks and benefits as with any medication.
Anyone familiar about how side effects are determined, would not really give much thought to them. If you are part of a pharmaceutical study and get diarreah, you have to tell and that is then turned into a side effect even if the diarreah was caused by stomach flu. That's why you'll hear so many drugs that list menstrual cramps as a side effect.
Just another reason to keep abortion legal in ALLof the US.
Come on people, chill out. Even with a random lot screw up like this, statistically overall the pill and other hormonal BC methods are going to be 98-99% effective. If you don't like the risk of an occasional screw up, you can always go to natural family planning, with it's success rate of something like 60%. Start planning your baby showers now.
As a women who has nearly died of a blood clot do to birth control pills, be very aware of the risks of taking them.
Are you a smoker?
LMAO..... Wow, birth control pills that help you get SUPER PREGNANT EXTRA FAST. This is why I dont take birth control. Me and my partner are responsible enough to know how to not have a baby. I dont want all those chemicals and crap in body anyways, I get enough of that from the crap they feed us. Looks like this may be a sign. Stop relying on medicine and learn to be responsible adults... Pull out, buy a condom, or shut up.
"Pull out?"
People do need to learn to be responsible. But they sure don't need to learn from you.
Or use the back door!
try having painful cysts on your ovaries.....people use birth control to control their hormones, to control their cysts...many reason other than not wanting to be pregnant.
I take The Pill for medical reasons...preventing unwanted children is an added benefit. I am over 40 and do not wish to have any more children. The rhythm method has been proven to be ineffective and if you have a hormonal imbalance isn't worth a hill of beans. The only method that 100% prevents child birth is abstinence, but who in a healthy marriage abstains? Not everyone can use condoms or other topical chemical forms of birth control...The Pill has many applications and when the packaging is wrong, it messes up more than just conception. It pays to be vigilant.
This is an absolute MESS. This opens up a terrible can of worms.....unwanted pregnancy leading to abortion; unwanted pregnancy leading to adoption; unwanted children being born into a family that resents them; unwanted pregnancy affecting women with various health issues. This is an absolute outrage. I hope this company is raked over the coals, and is held liable for any of the above scenarios. This affects the lives of thousands, on many different levels.
MSNBC has an erroneous link in the text. What do you think about it?