To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Voluntary Limited Recall of Ovcon 35 by Bristol-Myers Squibb URL: http://www.pslgroup.com/dg/1403A.htm Doctor's Guide January 17, 1997
PRINCETON, N.J., Jan. 17, 1997 -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that it is voluntarily recalling an individual lot (No. H6J272A) of the oral contraceptive Ovcon(R) 35 (norethindrone and ethinyl estradiol tablets, USP) from markets in the United States and its territories. The voluntary limited recall is effective immediately and involves only one single lot of Ovcon(R) 35, the 28-day dosing regimen. No other Ovcon or Bristol-Myers Squibb products are affected by the recall, and there is no significant health threat posed to women taking the product. Pharmacies and wholesale distributors are being advised in writing as to how to return all remaining inventory of this lot to the company for either a rebate or a replacement order. Women who have the affected packages or those who are not certain if their tablets are affected by the recall are advised to consult with their pharmacists. The company has received several reports of mispackaged product in which color-coded tablets are in reverse order of the package design. Ovcon(R) 35 is packaged in a blister-pack card which is placed in a compact containing four horizontal rows of seven tablets each, with each row representing a one- week dosing regimen. The first three rows (or weeks one through three) should have peach-colored tablets that contain active ingredient; the fourth row (or week four) should have green-colored placebo tablets that contain no active ingredient. Of the approximately 150,000 compacts of marketed product from Ovcon(R) 35 (Lot No. H6J272A), which are the only units subject to the recall, there have been reports concerning a few compacts in which the tablets for weeks one and four are transposed. It is highly unlikely that pregnancy would occur as a result of taking the mispackaged placebo tablets instead of the tablets with active ingredient. It is possible, however, that some women could experience irregularity in their menstrual cycle, which should correct itself when the normal dosing regimen is resumed. While there is no significant health risk involved with this situation, the company believes the limited recall is the prudent course of action in the best interests of women who use Ovcon(R) 35. The mispackaged product poses no significant health threat to women who may already have taken the incorrect tablets. Women who have the Ovcon(R) 35 from Lot No. H6J272A are advised to immediately return the package to their pharmacists for a replacement compact at no additional cost. Women with medical questions also should consult with their physicians. Women's questions concerning whether the tablets are from the recalled lot should be referred to their pharmacists. The U.S. Food & Drug Administration has been notified of this recall. Bristol-Myers Squibb is in the process of contacting customers who received shipments of the recalled lot. The Company's Quality Control group has reviewed the manufacturing and packing processes related to this product. This is an isolated incident, and corrective actions have been taken. Ovcon(R) is an oral contraceptive and is indicated for the prevention of pregnancy. Oral contraceptives are highly effective but have a 1 to 3% failure rate. The most common side effects of all oral contraceptives are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness and difficulty wearing contact lenses. The lot number is imprinted at the bottom of the foil-wrapped blister pack which contains the tablets inside the compact. Doctors, pharmacists or patients seeking additional information on the voluntary limited recall of Ovcon(R) 35 Lot No. H6J272A can call the Bristol-Myers Squibb Customer Relations Department at 1-800-332-2056. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.