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Manufacturer recalls prefilled Lunelle syringes. (Risk of Contraceptive Failure).

OB GYN News

| November 15, 2002 | Mechcatie, Elizabeth | COPYRIGHT 2002 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

All prefilled syringes of the monthly injectable contraceptive Lunelle are being voluntarily recalled by the manufacturer "due to a lack of assurance of full potency and possible risk of contraceptive failure," the Food and Drug Administration announced last month.

"A subpotent dose of Lunelle may not be effective in preventing pregnancy," the FDA said in a statement. The agency and the manufacturer, Pharmacia, are advising women who have been relying on Lunelle for contraception to seek the advice of their health care professional about using alternative methods of birth control and to use an additional barrier method "until beginning a new form of hormonal contraception."

The company is not aware of any pregnancies that have occurred as a result of this problem.

The recall does not include Lunelle packaged in vials, Bryant Haskins, a Pharmacia spokesperson, said in an interview.

The majority of women who have been using Lunelle are affected by this recall because most receive Lunelle from prefilled syringes rather than vials. Moreover, there are not enough Lunelle vials to make up for the loss of the prefilled syringes, so women will have to switch to other birth control methods for now, he said.

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Source: HighBeam Research, Manufacturer recalls prefilled Lunelle syringes. (Risk of...

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