FDA NEWS RELEASE
Contact: Caroline Bullock
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
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.