Drug Criteria & Outcomes: News Brief: Pharmacia announces recall of its contraceptive

Pharmacia Corp. has announced that it is initiating a voluntary recall of medroxyprogesterone acetate and estradiol cypionate injectable suspension (Lunelle Monthly Contraceptive Injection) 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 the prefilled syringe lots currently on the market. Medroxyprogesterone acetate and estradiol cypionate injectable suspension packaged in vials is not affected by this recall, nor is any other Pharmacia contraceptive product.

Medroxyprogesterone acetate and estradiol cypionate injectable suspension is a combined hormonal contraceptive that is administered to women by a health care professional as a monthly injection. A sub-potent dose of medroxyprogesterone acetate and estradiol cypionate injectable suspension may not be effective in preventing pregnancy. Women who have been using medroxyprogesterone acetate and estradiol cypionate injectable suspension as their contraceptive are advised to seek the advice of their health care 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.

For further information, health care professionals may call the Pharmacia medical information service on (800) 323-4204.