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Recall of the Week: Pfizer recalls 1 million birth control packets due to packaging error

Pfizer Inc. announced this week that it is recalling 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.

Pfizer LogoAn 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 company said in a statement.

The oral contraceptives were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products, and labeled under the Akrimax Pharmaceuticals brand. The birth control tablets are distributed to warehouses, clinics, and retail pharmacies nationwide.

As a result of the packaging error, the daily regimen for the oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Pfizer recommends women who used the recalled tablets should begin using a non-hormonal form of contraception immediately. Patients who have the recalled birth control pills – click here to see the lot numbers – should notify their physician and return the contraceptives to the pharmacy.

The birth control pills are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of the birth control pills is important in avoiding the risks of an unplanned pregnancy, according to Pfizer.

Any adverse events that may be related to the use of the birth control pills should be reported to Akrimax Medical Information at 877-509-3935, 8 a.m. to 7 p.m. Monday to Friday CST, or to FDA's Med Watch Program either online, by regular mail, or by fax.

Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: Mail to the address on the pre-addressed form.
Fax: 800-FDA-0178

Copyright 2012, Rita R. Robison, Consumer Specialist


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