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
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
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
- 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.
For more information about this recall,
call Barr Laboratories, Inc.'s Drug Information at (800) 222-0190, extension
Barr Laboratories, Inc.