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Pharmacia Corporation Announces Voluntary Recall of Lunelle™ Monthly Contraceptive Injection

FDA NEWS RELEASE

Contact: Caroline Bullock
(908) 901-8591
Bryant Haskins
(908) 901-7481

For Immediate Release

Pharmacia Corporation Announces Voluntary Recall of Lunelle™ Monthly Contraceptive Injection

PEAPACK, N.J. (October 10, 2002) - Pharmacia Corporation announced today that the company is initiating a voluntary recall of Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) in prefilled syringes due to a lack of assurance of full potency and possible risk of contraceptive failure. As a precaution, Pharmacia is voluntarily recalling all Lunelle prefilled syringe lots currently on the market. Lunelle packaged in vials is not affected by this recall, nor is any other Pharmacia contraceptive product.

Lunelle is a combined hormonal contraceptive (like the oral contraceptive pill) that is administered to women by a healthcare professional as a monthly injection. A sub-potent dose of Lunelle may not be effective in preventing pregnancy. Women who have been using Lunelle as their contraceptive are advised to seek the advice of their healthcare professional regarding alternative methods of birth control and to use an additional barrier method of birth control (such as male or female condoms, diaphragm, or spermicide) until beginning a new form of hormonal contraception.

Pharmacia is committed to the integrity and safety of its products and is undertaking this voluntary recall with the full knowledge of the Food and Drug Administration. The affected lots were distributed in the United States, Puerto Rico and the U.S. Virgin Islands during 2002 and all physicians, pharmacies, clinics and wholesalers who received these lots are being notified.

For further information healthcare professionals may call the Pharmacia medical information service on 1 800 323 4204. Patients may call the Pharmacia patient information service on 1-888-691-6813.

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