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.
