Updated June 09, 2015.
Out of approximately 470,000 packages of marketed Nortrel 7/7/7 ? 28 day that are subject to the recall, Barr 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.
The U.S.

Food and Drug Administration (FDA) has been notified of the recall. All manufacturing and packaging processes related to the product have been reviewed, and the Company said it believes that the mispackaging was an isolated incident limited to the lots in question and corrective actions have been taken.

Nortrel 7/7/7 ? 28 day is a generic version of Ortho-McNeil Pharmaceutical's Ortho-Novum® 7/7/7 oral contraceptive and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. It is supplied in a 28-day regimen.

Barr said that it is committed to the manufacture of quality pharmaceuticals and regrets the inconvenience the recall may have for customers. The Company said it was working closely with its customers to replace any product in their inventory from the lots in question. The Company recommends that women who have been using the affected lots of Nortrel 7/7/7 - 28 day and have questions seek the advice of their healthcare professional.

Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.