The contraceptive pill recall is a request to return to the maker a batch or an entire production run of contraceptive pills, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence (which can cause costly legal penalties) and to improve or avoid damage to publicity.
Around one million packets of birth control tablets are being recalled in the US, as they might not prevent pregnancy. The pharmaceutical company Pfizer said a "packaging error" meant the doses were not correct.
A manufacturing mix-up by Pfizer Inc., the world’s largest drug maker, led to some packets being distributed with the pills out of order. That means a patient could have unknowingly skipped a dose and raised her risk of an accidental pregnancy.
Pfizer is advising women affected to use non-hormonal forms of contraception immediately.
Fourteen lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and ethinyl estradiol tablets have been recalled.
This would not be the first example of a “wrongful pregnancy” case, according to I. Glenn Cohen, assistant professor and co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, who spoke with MyHealthNewsDaily:
"Similar cases have allowed people to sue for things like unwanted pregnancies after botched vasectomies. In the past, there has even been a case in which a woman successfully sued a pharmacist for a pregnancy that resulted from errors in filling the woman’s birth control prescriptions, Cohen said."
Pfizer Inc. announced today that it has voluntarily recalled 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. An 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 cause was identified and corrected immediately.
The affected packets have expiration dates between July 31, 2013 and March 31, 2014.
If many women get pregnant as a result of the botched pills, and a class action suit is large enough, Gianforcaro said there is the potential that it could put Pfizer out of business. “I don’t anticipate that happening here, but there’s always the possibility,” he said.
Company spokeswoman Kristen Neese said the drug maker learned about the problem when a customer called late last year to report finding a pink placebo tablet in the middle of her white birth control pills. The company found a manufacturing problem and fixed it immediately.
It issued a nationwide recall in late December asking pharmacies to pull the affected lots from their shelves. It then announced the recall Tuesday to consumers and the media after the Food and Drug Administration requested that.
The drug is not among the more commonly prescribed brands of birth control. The brand Lo/Ovral ranked 64th in U.S. birth control sales last year. The generic version, called norgestrel and ethinyl estradiol, ranked 30th, according to data firm IMS Health.
Pfizer has recalled about 1 million packets of Lo/Ovral-28 and its generic equivalent, but the company estimates that only about 30 packets were flawed. The pills were made and shipped last year.