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Recall of Nortrel 7/7/7 Due to Mispackaging Causes Increased Chance of Pregnancy

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:

• 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.

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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Barr Laboratories, Inc. Release

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