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

Internal Medicine News

| November 15, 2002 | 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

ELIZABETH MECHCATIE

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 using Luneile for contraception to get advice from their health care professional about using alternative forms 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 the problem.

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

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