Check Nortrel stock — Barr Labs issues recall
If you have any patients who use 28-day packages of Nortrel 7/7/7 oral contraceptives (OCs), be sure your clinic has initiated its patient notification plan following the July 9, 2003, voluntary recall issued by the pill’s manufacturer, Barr Laboratories of Pomona, NY.
Three lots, which total about 470,000 packages, are involved in the recall: 290122001, 290122002, and 290122003. The lot numbers should appear in a window labeled "LOT" on the upper right-hand corner of the backside of the package. Any Nortrel 7/7/7 28-day product that does not have a number in that location also is subject to the recall; no other lots of Nortrel or other Barr OC products are affected by the recall.
The recall was issued by the manufacturer after it received two reports that color-coded tablets in the blister card packaging of the product were reversed, which caused the white placebo row to be in the first row labeled "start," rather than in the last row labeled "week 4." The lot number and expiration date were not visible on the back of these two cards, states the company.
Nortrel 7/7/7 28-day pills are packaged in a blister card containing four horizontal rows of seven tablets each, with each row representing one week of tablets. The top row contains yellow tablets, followed by rows of blue, peach, and white tablets. The colored tablets contain the active hormonal ingredients of ethinyl estradiol and norethindrone; the white tablets are placebos that contain no active ingredient.
The company has strived to be proactive in issuing the recall, says Anna Manno, communications associate for Barr Laboratories. The federal Food and Drug Administration has been notified of the recall, and the company has reviewed all manufacturing and packaging processes related to the product. According to a press release issued by the company, the mispackaging was an isolated incident limited to the lots in question, and corrective actions have been taken.
Product recalls of the Norplant contraceptive implant in 2000 and the Lunelle contraceptive injection in 2002 caused headaches for many family planning clinics; the Nortrel 7/7/7 recall may not have appeared as urgent, observes Michael Rosenberg, MD, MPH, clinical professor of obstetrics and gynecology and adjunct professor of epidemiology at the University of North Carolina at Chapel Hill and president of Health Decisions, a private research firm specializing in reproductive health.
Results from prior Contraceptive Technology Update (CTU) contraception surveys bear out this observation. While the brand equivalent, Ortho 7/7/7 (Ortho-McNeil Pharmaceutical, Raritan, NJ) was once a popularly prescribed pill, its dominance waned following the introduction of lower-dose OCs. A total of 12% of CTU readers named Ortho 7/7/7 as their No. 1 pill for 21-year-old women in 1996; however, by 1999, that number had decreased to 5%. Ortho 7/7/7 has failed to chart in subsequent CTU surveys. Barr Laboratories introduced its version of the pill in January 2003.
Check patient guidance
Women who are using Nortrel 7/7/7 28-day packages should be instructed to carefully check their blister cards and take the following steps:
• If their blister card contains out-of-sequence tablets, women should continue taking the pills, and return the product to their pharmacist for a replacement blister card. Barr Laboratories will replace any out-of-sequence blister card at no additional cost and also will 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, women should continue taking the product.
• Women who are not certain whether their blister card contains the correct sequence of tablets should contact Barr Laboratories or their pharmacist immediately, but should continue taking the product until otherwise instructed by their provider 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 provider for further instructions.
To receive reimbursement for the reasonable and customary cost of a pregnancy test, the patient must provide proof that she is or was in possession of one of the effected lots of product or a copy of her prescription from her pharmacist, and a copy of the receipt for the pregnancy test. This information should be mailed to Barr Laboratories, Attention: Drug Information, Two Quaker Road, Box 2900, Pomona, NY 10970.
More information on the recall and the reimbursement process is available by call the company’s information department at (800) 222-0190, ext. 33302.
If you have any patients who use 28-day packages of Nortrel 7/7/7 oral contraceptives (OCs), be sure your clinic has initiated its patient notification plan following the July 9, 2003, voluntary recall issued by the pills manufacturer, Barr Laboratories of Pomona, NY.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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