Counterfeit Emergency Birth Control Medication May be in US Drug Supply Chain, FDA Warns

August 11, 2011 11:40 am Topics: Counterfeit drugs

FDA warns consumers not to use the emergency birth control product labeled as Evital, as these products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy. FDA stresses that Evital has not been approved by the FDA for use in the US. FDA specifies that the product labeled Evital may also be in distribution in some Hispanic communities in the US. An image of the packaging is included in an FDA news release. FDA reports that the labeling includes the following text “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet,” by “Fluter Domull.” Consumers should not use a product if it matches this description and should contact their health care provider if they have taken such a product and experienced any side effects or adverse reactions. FDA reminds consumers that there are FDA-approved emergency birth control medicines available both with a prescription, and OTC without a prescription for women 17 years old or older. Anyone with information or questions about the unapproved Evital product can send a confidential e-mail to CDER_Ingredient_Adulteration@fda.hhs.gov.