Navigation Links
Unapproved Emergency Birth Control Medicine Possibly in U.S. Distribution May Be Ineffective and Unsafe
Date:8/1/2011

SILVER SPRING, Md., Aug. 1, 2011 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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.  

The packaging label of the potentially ineffective and suspect counterfeit version says, "Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet", by "Fluter Domull" :

  • Contact your doctor or health care professional if you have taken Evital labeled as the 1.5 mg tablet and experienced any problems.
  • 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).
  • You should talk with a doctor, pharmacist, or health care professional to find the FDA-approved emergency birth control medicine best for you.

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.htm
  • Download form 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:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Shelly Burgess 301-796-4651; shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
2. United States Seizes Unapproved Ozone Generators
3. Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs
4. FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine
5. FDA Issues Warnings to Marketers of Unapproved Chelation Products
6. FDA Consumer Health Information - FDA Tightens Reins on Unapproved Chelation Drugs
7. FDA Prompts Removal of Unapproved Drugs From Market
8. FDA CONSUMER HEALTH INFORMATION - FDA Intends to Remove Unapproved Drugs From Market
9. Many Heart Attack Patients Dont Get Best Emergency Treatment
10. MedicAlert Foundation Joins The Alzheimers Association to Offer MedicAlert(R) + Alzheimers Association Safe Return(R) - Live 24-Hour Emergency Response for Wandering and Medical Emergencies
11. Hospital Launches Landmark Emergency Medicine Project
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016 ... George Phillips und Stephen ...    ArisGlobal®, ein führender Anbieter ... gab heute bekannt, dass neue Führungskräfte zum ... gestoßen sind, die vielfältige Erfahrungen mitbringen.  Dies ...
(Date:4/28/2016)... -- Treato , the single largest ... that it has been named a Cool Vendor by ... Sciences, 2016, Stephen Davies , Michael ... life-science- oriented analytics, algorithms and smart machine technology in ... medication ingestion, and analyze unstructured information.   ...
(Date:4/28/2016)... , April 28, 2016 Dr. ... and Ste phen ... ArisGlobal®, a leading provider of cloud-based software solutions for life ... Pharmacovigilance team to bring a wealth of insight to a growing ... pharmacovigilance knowledge. George Phillips joined ArisGlobal in ...
Breaking Medicine Technology:
(Date:4/30/2016)... ... April 30, 2016 , ... Orlando-based Maximized Living has ... go for gold in Rio. Under the care of Maximized Living doctors at ... In an unprecedented showing, Maximized Living is sending the largest contingent of elite chiropractors ...
(Date:4/29/2016)... ... April 30, 2016 , ... Mercy College is expanding ... The following programs will be expanding due to high demand: Master of Business Administration ... will begin this summer. , School of Business Graduate Program Chair Dr. ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... ... Two Ten Footwear Foundation, the national charitable foundation serving the footwear industry, has ... 8,000 volunteers representing more than 130 companies across 23 states during the months ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula for ... and mood optimization products to the store is just one more way Shamangelic ...
(Date:4/29/2016)... ... April 29, 2016 , ... On Tuesday, April 26, 2016 members ... celebrated the signature of Gov. Nathan Deal on SB 258, the “Rural Health Care ... Cumming), offers a 70% tax credit to individuals and corporations which donate directly to ...
Breaking Medicine News(10 mins):