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The Food and Drug Administration today announced that Barr Laboratories is
voluntarily recalling three lots of its Nortrel 7/7/7 – 28 day (norethindrone
and ethinyl estradiol tablets, USP) oral contraceptive due to packaging errors
that could lead to an increased pregnancy risk.
The recall is effective
immediately and involves Lot Numbers 290122001, 290122002, and 290122003 only.
The company has provided the following information to consumers.
Nortrel 7/7/7 – 28 day is packaged in a blister card containing four horizontal rows of seven tablets each, with each row representing one week of tablets. The first (i.e. top) row should contain yellow tablets. The second row should contain blue tablets. The third row should contain peach tablets. The fourth (i.e. bottom) row should contain white tablets. The colored tablets contain the active hormonal ingredients. The white tablets are placebos that contain no active ingredient.
Any woman who has received a Nortrel 7/7/7 – 28 day blister card with
tablets in the wrong color 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.
Women taking Nortrel 7/7/7 –
28 day should carefully check their blister cards and take the following steps:
The Company said that out of approximately 470,000 packages of marketed Nortrel
7/7/7 – 28 day that are subject to the recall, it has received two reports
in which the tablets in the blister are reversed, causing the white placebo
row to be in the first row labeled “start” (i.e., week one) rather
than in the last row labeled “Week 4”. Additionally, the lot number
and expiration date were not visible on the back of these two cards.
Nortrel, an oral contraceptive that is a generic form of Ortho-Novum 7/7/7,
is sold in pharmacies. The recalled lots were distributed between January and
April 2003.
Doctors, pharmacists and consumers seeking additional information
on the voluntary limited recall of Nortrel 7/7/7 – 28 day should call
Barr Laboratories, Inc. Drug Information Line at 1-800-222-0190 extension 33302.
Any adverse reactions experienced with the use of this product should be
reported to FDA's MedWatch program by phone at 1-800-FDA-1088, by facsimile
at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD
20852-9787, or on the MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/.
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