Oral contraceptives recalled

February 2, 2012

An immediate voluntary recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets?about 1 million packets?was issued on February 1 by Pfizer after an internal investigation reported that some of the blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence, increasing the risk of an unintended pregnancy among women using the pills for contraception.

An immediate voluntary recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets-about 1 million packets-was issued on February 1 by Pfizer after an internal investigation reported that some of the blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence, increasing the risk of an unintended pregnancy among women using the pills for contraception.

Pfizer notified the US Food and Drug Administration, healthcare providers, and consumers of the recall on February 1.

Akrimax Pharmaceuticals distributed the product to warehouses, clinics, and retail pharmacies throughout the United States. The pills are sold in packs containing 21 tablets of active ingredients and 7 tablets with inactive ingredients. Expiration dates printed on the affected lots are from July 31, 2013 through March 31, 2014.

A complete list of lot numbers for the branded and generic formulations is posted at http://www.fda.gov/Safety/Recalls/ucm289770.htm. FDA and Pfizer advise women who have packets of pills in the affected lots to notify their physicians, return the product to the pharmacy, and begin using a second form of birth control immediately.

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