Practitioners' Reporting News

Barr Recalls Nortrel® 7/7/7

Issued August 29, 2003

Barr Laboratories, Inc. initiated a voluntary recall of its Nortrel® 7/7/7 (norethindrone and ethinyl estradiol–triphasic regimen), 28-day oral contraceptive. This recall was initiated from two reports submitted to the company. One of those reports was submitted to the USP Medication Errors Reporting (MER) Program and involved a woman, who took this product for three days before she realized the tablets were not in the proper sequence.

The recall involves the following lot numbers:

290122001

290122002

290122003

The lot number should appear in a window labeled "LOT:" on the upper right-hand corner of the back side of the package. Packages that do not bear a lot number in that location are also subject to the recall.

Nortrel 7/7/7 is packaged in a blister card containing four horizontal rows of seven tablets each, with each row representing one week of tablets. The first row should contain yellow tablets (labeled "Start"). The second row should contain blue tablets (labeled "Week 2"). The third row should contain peach tablets (labeled "Week 3"). The fourth row should contain white tablets (labeled "Week 4"). The colored tablets contain the active ingredients and the white tablets contain no active ingredient.

Nortrel® 7/7/7
Picture of Nortrel 7/7/7, 28-day in proper sequence
(obtained from Barr Web site)

The two reports involved the white tablets appearing in the first row labeled "Start." In addition, the lot number and expiration date were not visible on the back side of these blister cards.

Barr is encouraging women who are currently taking Nortrel 7/7/7 to carefully examine their blister cards to confirm that the color-coded tablets are packaged in the proper sequence. Any woman who has received a Nortrel 7/7/7 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.

Healthcare practitioners or women seeking additional information on this recall are encouraged to call Barr at 1-800-222-0190, extension 33302. To view the full content of the news release, visit www.barrlabs.com/pages/nprpr.html.

Practitioners are encouraged to report similar medication errors to the USP MER Program at www.usp.org/patientSafety/mer/. Reporting forms can also be printed at that address or requested by calling 1-800-23-ERROR (1-800-233-7767).


Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.