Nortrel 7/7/7 Birth Control Pill Recalled
Date of recall:
July 9, 2003
What is being recalled:
Barr Laboratories is voluntarily recalling three lots of its Nortrel 7/7/7 28- day birth control pills. The pills in these oral contraceptives may have been improperly packaged, which may increase the risk of unintentional pregnancy.
The recall is effective immediately and involves about 470,000 packages with the following lot numbers:
The lot numbers should appear in a window labeled "LOT:" located on the upper right-hand corner of the back of the package. No other lot numbers are affected by this recall. But any Nortrel 7/7/7 28-day product that does not have a lot number is also subject to the recall.
The Nortrel 7/7/7 28-day is packaged in a blister card with four rows of pills. The first row should contain yellow tablets, the second blue tablets, the third peach tablets, and the fourth white tablets. Each of the different colored tablets contains varying levels of active hormonal ingredients and the white tablets are placebo pill.
The company initiated the recall after it received two reports in which the white placebo tablets were in the first or "week one" row rather than in the last row labeled "week four." In addition, the lot number and expiration date were not visible on the back of the package.
According to Barr, a woman who has received a Nortrel 7/7/7 28-day blister card with tablets in the wrong sequence could be at an increased risk of pregnancy. In addition, changes to the menstrual cycle, including delayed bleeding, irregular bleeding, or spotting, may occur.
What to do:
Barr recommends that women taking Nortrel 7/7/7 28-day carefully check their blister cards and take the following steps:
- If your blister card contains out-of-sequence tablets, DO NOT STOP taking the product, but immediately consult with your health-care practitioner for further instructions and return the product to your pharmacist for a replacement blister card. The company will replace any out-of-sequence blister card at no additional cost and will also cover the cost of a pregnancy test for any woman who purchased and used a blister card with out-of-sequence tablets.
- If your blister card contains the correct sequence of tablets, continue taking the product.
- If you are not certain whether your blister card contains the correct sequence of tablets, contact Barr Laboratories or your pharmacist immediately, but continue taking the product until otherwise instructed by your health-care practitioner or pharmacist.
- If you believe you may have previously taken Nortrel 7/7/7 28-day from an out-of-sequence blister card and are concerned about pregnancy or irregular bleeding, consult your health-care practitioner for further instructions.