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SafetyAlerts
October 11, 2002

Pharmacia Corporation Has Recalled Lunelle? Monthly Contraceptive Injection

PEAPACK, N.J. (SafetyAlerts) - The Food and Drug Administration (FDA) said that Pharmacia Corporation has recalled 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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.