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Pfizer announces recall of oral contraceptives

Wednesday February 1, 2012
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Pfizer announced Wednesday a voluntary recall of 14 lots of the oral contraceptive Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol (generic) Tablets for U.S. customers.

An investigation by the manufacturer found some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. Pfizer said the cause was identified and corrected immediately.

The tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. The 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, according to Pfizer. 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.

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 to avoid the associated risks of an unplanned pregnancy.

Patients who have the affected product should notify their physician and return the product to the pharmacy. A list of the identification numbers of the recalled lots is available at http://on.pfizer.com/z75iAy.


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