Birth Control Recall: Norgestimate and Ethinyl Estradiol Tablets Recalled Over Packaging Errors

For the second time this year, certain birth control medications are being recalled over a packaging error.

Glenmark Generics Inc. has announced a voluntary recall of seven lots of its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.

Glenmark Generics explained how the error occurred:

The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.

Birth control pills are intentionally packaged in a specific order to provide protection from pregnancy. In these specific recalled pills, 21 tablets contain hormonal compounds to prevent pregnancy, while the last seven tablets don't contain any active ingredients. If a woman takes the pills out of order or takes inactive pills thinking they are active, she may be at risk of pregnancy.

"With birth control pills, if the exact count or sequence is out of order the efficacy of the birth control pill could be significantly decreased. If this is the case, patients may be experiencing irregular bleeding and may be at higher risk for unintended pregnancy," Dr. Adam Jacobs, assistant professor of obstetrics, gynecology and reproductive science at Mount Sinai Medical Center, told Everyday Health.

The company noted that there are no other health risks associated with the recall. [For more information on which lots of the birth control were recalled, click here.] People who find that one of their birth control packs is affected by the recall should tell their doctor and return the birth control to the pharmacy.

Earlier this year, Pfizer announced its recall of 1 million packages of its Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets, because some of the birth control tablets may be out of sequence, or there may be more of the active pills in some packages and more inactive pills in other packages.

Comments

[fadedrose45]

01:05 PM on 02/29/2012

Are they going to pay for the unplanned pregnancies? They will need food, clothing, shelter and a schooling fund. I hope they have some extra love for the women who dislike kids and are using birth control until they are old enough to get spayed/fixed.

[yakmon]

10:44 PM on 02/28/2012

And they say we can't trust meds from Canada???

Who $ays?

[crystalgeode247]

09:15 PM on 02/28/2012

Norg-Estimate BCP's aptly named

[onionboy]

12:16 PM on 02/28/2012

Packing error translates to:

"You're taking placebos when you think you're protected from accidental pregnancy"

[Satur9]

02:28 PM on 02/28/2012

Except they're differently colored and the packaging tells you which color pill has drug and which does not, so only an idiot would not be able to understand the very plain instructions printed on these.

[onionboy]

02:39 PM on 02/28/2012

Except in this case the packaging incorrectly tells you which pill has drug and which doesn't because it's labelled (incorrectly) on the blister pack when the pills are out of order.

That's the whole point of the story.

[warsaw]

09:14 AM on 02/28/2012

I imagine these pills were recalled in the US only. Not Canada, UK or any other country?

I don't know how I became so skeptical about these things.

[Julia Bailey]

09:49 AM on 02/28/2012

From the link listed above - These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. This product is distributed by Glenmark Generics Inc. only in the USA.

[kathleenruddy]

08:12 AM on 02/28/2012

In 2007, the World Health Organization's International Organization for Research on Cancer declared that oral contraceptives were Group I carcinogens, known to cause cancer in humans - specifically, breast and liver cancers. Using oral contraceptives prior to a first full-term pregnancy increases a woman's risk for premenopausal breast cancer by 40%. References to the WHO report are posted on my website: Breast Health and Healing Foundation

[Jack Gillespie]

07:24 AM on 02/28/2012

These packaging errors reveal a subconscious hatred for women, does it not?

[Satur9]

02:29 PM on 02/28/2012

Are you kidding? This stuff happens, jeez.

[bryan broome]

06:17 AM on 02/28/2012

Doesn't Glenmark Generics understand recall protocol. Someone has to d ie first. Or is that only Gov't procedure.

[Amalek]

11:45 PM on 02/27/2012

Wise business decision.  Reduce inventory before the pill is made illegal when Santorum takes office.

[thomasgwilliams]

11:03 PM on 02/27/2012

What kind of production Quality Assurance program allows for this many to get by the inspection and testing/verification process and get out of the facility and into the supply chain? What penalty will they face that has any real meaning? A slap on the wrist system preferred by conservatives and corporate right wingers is not working and the argument that they self regulate to avoid the issues of a bad reputation and liability is a sham when they use a cost to benefit analysis that says they can accept a certain amount of mistakes without significant impact on profits.

[bluecub]

10:48 PM on 02/27/2012

See, Santorini was right. Ban it. Burn her! Burn her!

[sarasu]

10:20 PM on 02/27/2012

Gee,was it maybe they were offshored, and made in India?

[cccoyote]

03:02 AM on 02/28/2012

Drug maker Glenmark Generics recalled birth control pills due to a packaging error that could make the pills ineffective. The pills are labeled as "norgestimate and ethinyl estradiol tablets." The India-based company issued the recall on Friday.

[rMatey]

10:13 PM on 02/27/2012

I'd almost suspect that there were evangelical GOPers working in those packaging facilities.

[OGalaxy]

03:55 AM on 02/28/2012

I'm not usually prone to conspiracy theories but when I saw the headline, it crossed my mind that the GOP could be behind this: "See, birth control pills are BAD!"

[fisher65]

10:08 PM on 02/27/2012

funny this never happened before! its a sick joke!

[Satur9]

02:30 PM on 02/28/2012

it does, it just never reaches you

[futbol4fun]

09:50 PM on 02/27/2012

I thought they might have been packaged in a Scooby-Doo dispenser.