Pfizer recalls Lo Ovral 28 And Norgestrel Ethinyl Estradiol Tablets


Pfizer Inc. announced 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.

Lo/Ovral-28 and Norgestrel and Ethinyl Estradiol Tablets - oral contraceptives:

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.

Packaging error and health risks:

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.

Identify and Notify:

Patients who have the affected product 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.

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.htm1

Regular Mail:
Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. 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.


(Anita Kumar -- sub-editor compiled and published Pfizer recalls Lo Ovral 28 And Norgestrel Ethinyl Estradiol Tablets at HealthNewsTrack on February 1, 2012 sourced from Pfizer - http://www.pfizer.com/)

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Current news
Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral?-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Possibility Of Inexact Tablet Counts Or Out Of Sequence Tablets

What is Birth control?
About Birth control -- Birth control is voluntary method of fertility control of the number of children conceived, by planned use of different contraceptive techniques of contraception to prevent pregnancy.


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