Oct. 11, 2002 -- Concerns about a potential lack of potency and contraceptive failure have prompted the recall of thousands of Lunelle monthly contraceptive injections. The manufacturer today announced that it cannot assure the potency of the pre-filled syringes, and their use may result in pregnancy unless other forms of birth control are used.
In cooperation with the FDA, Pharmacia Corporation has initiated a voluntary recall of all prefilled syringe lots of the contraceptive currently on the market. The company says Lunelle that comes packaged in vials is not affected by the recall, nor is any other Pharmacia contraceptive product.
Lunelle is a monthly hormonal injection that is given to women by a healthcare professional. It works like the oral contraceptive pill and uses a combination of hormones to prevent pregnancy by stopping the release of eggs from the ovaries.
According to Pharmacia, a sub-potent dose of Lunelle may not be effective in preventing pregnancy. The company advises women who have been using Lunelle to seek the advice of their healthcare professional about alternative methods of birth control during the recall, and use a barrier method of birth control (such a condom, diaphragm, or spermicide) until beginning a new form of hormonal contraception.
The lots in question were distributed during 2002 in the U.S., Puerto Rico, and the U.S. Virgin Islands. Pharmacia says that physicians, pharmacies, and wholesalers who received these lots are being notified.
For more information, consumers may call the Pharmacia patient information service on (888) 691-6813 or visit www.lunelle.com. -->