Pfizer initiated a recall effort involving more than 1 million packets of birth control pills on Wednesday. The company has said that the pills may have faulty packaging, which means that they could be out of sequence or have the incorrect mix of active and inactive ingredients.
Which birth control pills are being recalled?
Pfizer is recalling 28 different lots of the birth control pill Lo/Ovral-28 and its generic version, norgestrel/ethinyl estradiol. There are 14 lots of each type being recalled. The company provided lot numbers for the affected pills at the end of their official press release, which was posted to both its website and that of the FDA on Wednesday.
The pills were manufactured by Pfizer, but were not distributed by them. Instead they were sold through a partner company, Akrimax Rx Products, which is the entity that appears on the pills' packaging. Pfizer itself, however, has taken responsibility for the errors that have led to the recall.
What exactly is supposed to be wrong with the pills?
Pfizer said that the pills essentially were packaged incorrectly, not defective. The issue is that in being packaged incorrectly, the pills may have been improperly sequenced, meaning that the active pills would be mixed in with the inactive pills or vice versa. Also, the company is saying that the proper number of active and inactive pills may be incorrect in some packages as well.
What this means essentially is that the affected packages may not effectively prevent pregnancy in women that are relying solely on them to do so, according to Medpage Today. Birth control packets are meant to contain 21 active pills and seven inactive pills. Taking the pills out of sequence reduces or negates their effectiveness.
Were all 1 million packets that Pfizer is recalling packaged incorrectly?
Not necessarily. In a separate statement, the company maintained that if even one packet was potentially incorrect, it made sense to voluntarily recall all of them in order to prevent the possibility of a larger issue and to ensure the safety and effectiveness of the company's product. The error was initially discovered by the company itself, which reported the issue to the FDA before initiating the recall.
How does Pfizer know that only these lot numbers were affected?
Pfizer has claimed that the company did extensive testing after the discovery of the initial problem. In one of its two press statements on Wednesday, the company asserted that the underlying cause of the issue had been found and fixed.
What are Pfizer and the FDA recommending for women who may have pills from the affected lots?
Take the pills back to their nearest pharmacy and return them. Both the FDA and Pfizer have recommended that women use a non-hormonal form of birth control as a back-up. Doctors and gynecologists are advising women who have been taking pills from the affected lots to also take a pregnancy test to make sure they are not pregnant, according to Medical News Today.
Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.