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Pfizer Recalls Birth Control Pills

Pfizer recently recalled about 1 million packets of birth control pills due to a packaging error that could increase the likelihood of pregnancy.  The recalled pills included 14 lots of Lo/Ovral-28 birth control pills and 14 lots of generic Norgestrel and Ethinyl Etstradiol pills, all of which were marketed by Akrimax Rx Products and have expiration dates between July 31, 2013 and March 31, 2014.

Birth control pills typically contain 21 days of active pills and 7 days of placebo pills, but some of the recalled packets contained too many active pills, others contained too few active pills, and still other packets contained active and inactive pills that were out of sequence.

“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,” Pfizer said in a statement. “…Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.”

Pfizer first learned of the problems with the pills when a customer complained to the company last October that she noticed that her package of pills did not contain the right amount of active and placebo pills.  Upon further investigation, Pfizer learned that some packages of pills contained an extra active pill at day 22 or 28, one pack lacked an active pill at day 10, and another pack lacked an inactive pill at day 24.  Pfizer notified pharmacies and distributors of the affected birth control pills on December 28, 2011 that it was recalled the pills.

Neither the U.S. Food and Drug Administration (FDA), nor Pfizer, have received any reports of adverse events, such as unintended pregnancies, but the FDA is investigating the matter.  Women who do not take the correct amount of active pills in a one month cycle risk unintended pregnancy because they could ovulate without the proper hormonal dosage designed to prevent ovulation.  Pfizer is advising women who have used the affected pills to consult with their doctors.

Many experts have begun speculating about whether the Pfizer recall could potentially lead to individual or class action lawsuits for any unwanted pregnancies.  Product liability laws protect consumers from dangerous or defective products, including unsafe pharmaceuticals, due to design defects, manufacturing errors, or failures to warn the public of a potential risk associated with the product.

The Chicago product liability and medical malpractice attorneys at Steinberg, Goodman & Kalish are dedicated to protecting victims of personal injury, medical malpractice and product liability claims, including medical device recalls and unsafe pharmaceuticals.

Source: Pfizer Cites Packaging Flaws in Birth-Control Pill Recall

 

Steinberg Goodman & Kalish  (www.sgklawyers.com) is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.