Lunelle™ Monthly Contraceptive Injection Recalled
Peapack, N.J. (October 10, 2002) - Pharmacia Corporation announced 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. This recall applies to ALL Lunelle prefilled
syringe lots currently on the market. Lunelle packaged in vials is not affected
by this recall.
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 contact their
healthcare professional regarding whether they received the prefilled syringe
or the vial packaging. If you received Lunelle from the prefilled syringe,
alternative methods of birth control should be used immediately.
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
Created: 11/23/2002  - Donnica Moore, M.D.