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Birth Control Recall: Pfizer Warns of Unintended Pregnancies

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Posted on Feb 1, 2012
FDA

The pharmaceutical manufacturer says the million packets of mis-packaged birth control pills it is recalling won’t harm women’s health, but it acknowledges that they could fail to prevent users from becoming pregnant.

The affected pills were shipped nationwide and marketed under the Akrimax brand.

Click here for more information and the lot numbers being recalled.  —PZS

Pfizer’s press release:

FOR IMMEDIATE RELEASE - January 31, 2012 - NEW YORK, N.Y. – Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately.

These products are oral contraceptives indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. These tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. This product is distributed to warehouses, clinics and retail pharmacies nationwide.

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.

These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy. Correctly packaged blister packs are pictured here.

Any adverse events that may be related to the use of these products should be reported to Akrimax Medical Information at 1-877-509-3935 (8 AM to 7 PM Mon-Fri CST) or to FDA’s Med Watch Program either online, by regular mail or by fax.

Online:          www.fda.gov/medwatch/report.htm
Regular Mail:  Use postage-paid, pre-addressed Form FDA 3500
                  available at: www.fda.gov/MedWatch/getforms.htm. Mail
                  to the address on the pre-addressed form.
Fax:            1-800-FDA-0178

Pfizer has responded rapidly to ensure that its products continue to meet the company’s high quality standards. The safety of patients who take our medicines is our first priority.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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