The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.
Evital has not been approved by the FDA for use in the United States. This potentially ineffective and suspect counterfeit emergency birth control may also be in distribution in some Hispanic communities in the United States. And bears the following white with yellow and black label, “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet”, by “Fluter Domull&rdquo. If you see this packaging, DO NOT Take the product. If you have, contact your doctor or healthcare professional immediately.
There are FDA-approved emergency birth control medicines available both with a prescription, and over-the-counter without a prescription (if you are 17 years old or older). All women are advised to talk with a physician, pharmacist, or health care professional to find the FDA-approved emergency birth control medicine best for you. Readers can also get in touch with Planned Parenthood of Southern New England, 345 Whitney Ave., New Haven, CT 06511 203 865-5158
FDA is asking for help from consumers who have information about Evital.
Please send an email to CDER_Ingredient_Adulteration@fda.hhs.gov to provide information or if you have more questions.
Any information received is confidential and will be used only to help in FDA’s effort to remove the potentially unsafe and ineffective versions from the U.S. marketplace.
Health care professionals and consumers are asked to report adverse events related to the use of suspect counterfeit versions of Evital to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm1
- Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For more information about counterfeit medicine, click on link below: