The recall is effective immediately and involves Lot Numbers 290122001, 290122002 and 290122003. The Lot Numbers should appear in a window labeled "LOT: "on the upper right-hand corner of the back side of the package. Any Nortrel 7/7/7 – 28 day product that does not bear a Lot Number in that location is also subject to the recall. No other lots of Nortrel or other Barr oral contraceptive products are affected by this recall. Doctors, pharmacists or women seeking additional information on this recall are encouraged to call Barr Laboratories, Inc.’s Drug Information at 1-800-222-0190 extension 33302.
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 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.
The Company recommends that women taking Nortrel 7/7/7 – 28 day carefully check their blister cards and take the following steps:
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If their blister card contains out-of-sequence tablets, they should continue taking the product, immediately consult with their health care practitioner for further instructions and return the product to their 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 their blister card contains the correct sequence of tablets, they should continue taking the product.
Women who are not certain whether their blister card contains the correct sequence of tablets should contact the Company or their pharmacist immediately, but should continue taking the product until otherwise instructed by their health care practitioner or pharmacist.
Women who believe they may have previously taken Nortrel 7/7/7 – 28 day from an out-of-sequence blister card and who are concerned about pregnancy or irregular bleeding should consult their health care practitioner for further instructions.
