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Barbara Nicol, M.D.
St. Luke's Health Care Center
San Francisco, CA
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 (800) 323-4204. Patients may call the
Pharmacia patient information service on (888) 691-6813. You may also
refer to http://www.lunelle.com.
Media Contacts:
Caroline Bullock
Phone: (908) 901-8591
Bryant Haskins
Phone: (908) 901-7481
Analyst Contact:
Alex Kelly
Phone: (908) 901-8853
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Barbara Nicol MD
St. Luke's Health Care Center
San Francisco CA USA
