February 2, 2012
Birth control pills are known to be nearly 100 percent effective when taken properly, but a recall of the drugs could send a shudder through women of childbearing age.
Pfizer Inc., the world's largest drugmaker, has recalled about 1 million packets of Lo/Ovral-28 and its generic equivalent after a manufacturing mix-up led to about 30 packets, according to Pfizer estimates, 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.
Each packet contains 28 color-coded pills, with 21 containing the active ingredient that prevents pregnancy and seven that act as placebos. Doctors say taking three placebos or more in a row negates the pregnancy protection.
Pfizer spokeswoman Kristen Neese said the drugmaker 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, but did not announce the recall to consumers and the media until Tuesday.
Neese said Pfizer did not announce the recall publicly in December due to the relatively small size of the problem and the low risk to patient safety.
The recall includes 14 lots of Lo/Ovral-28 tablets and 14 lots of the generic version. Both products are manufactured by Pfizer and sold in the United States by Akrimax Rx Products. Pfizer said the packets are pink with the drug's brand name or generic name on it, along with the Akrimax name. Pfizer's logo does not appear on it.
Patients who received a packet from one of the affected lots should call their doctors immediately, said Dr. Adam Jacobs, division director of family planning at Mount Sinai Medical Center. If they have had unprotected sex in the past five days while on one of those pill packets, they may want to consider emergency contraception.
The affected packets have expiration dates ranging between July 31, 2013, and March 31, 2014. Lot numbers are available on the FDA website.