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Pfizer Recalls Birth Control Pills

Detroit Law Firm Will Handle Lo/Ovral-28 Claims

Attorney Brian J. McKeen announced that his Detroit law firm, McKeen & Associates, PC, will begin handling claims related to the Pfizer birth control pill recall. The recall, which was issued by Pfizer on Feb. 1, involves birth control pills marketed under the name Lo/Ovral-28. The generic version of the pill, sold under the name norgestrel and ethinyl estradiol, is also covered by the recall order. Nearly 1 million packets of birth control pills are affected.

Packaging Error Could Lead to Unplanned Pregnancies

The action was taken in response to packaging errors on packets with expiration dates from July 31, 2013 to March 31, 2014. The mistake resulted in some packages having either too few or too many active pills, or active and inactive pills being supplied in the wrong sequence. As a result, women using this method of birth control could receive inadequate contraception if they took the inactive pills in the belief that they were active.

Contraceptive pills such as Lo/Ovral -28 work by regulating a woman’s menstrual cycle to prevent ovulation. Without the correct sustained dose of active ingredients, ovulation could occur, leaving women at risk for unplanned pregnancies.

General Announcement of Recall Delayed

The pills were recalled in December, when Pfizer issued a recall order to pharmacies to remove the affected lots from their inventories. A public announcement to consumers and the media was not made until this week, however, in response to a Food and Drug Administration request.

Pfizer spokeswoman Kristen Neese said that a general announcement was not made at the time of the initial recall because of the small number of packets affected, estimated by the company to be as few as 30 lots. But a lot can represent tens of thousands of individual packets, meaning that many women could be affected.

Potential Risks for Women

Doctors consulted after the announcement warned that although Pfizer is downplaying the significance of the recall, there are real risks to women who rely on Lo/Ovral-28 to prevent pregnancy. “This is extremely important,” said Dr. Steven Goldstein, professor of obstetrics and gynecology at NYU Langone School of Medicine in New York City. “It is absolutely essential that birth control pills be taken as intended, with 21 medicated pills in a row. Otherwise ovulation could take place and an unintended pregnancy is definitely a possibility.”

Some have suggested that women using Lo/Ovral-28 or its generic equivalent might wish to consider pregnancy tests or emergency contraception if they have had unprotected sex in the past five days. This is particularly true for women who should not become pregnant for medical reasons.

Lo/Ovral-28 and its generic equivalent are manufactured and marketed for Pfizer by Akrimax Pharmaceuticals. Pfizer’s name and logo do not appear on the packaging.

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