Navigation Links
FDA Warns Consumers to Stop Using Soladek Vitamin Solution
Date:3/28/2011

SILVER SPRING, Md., March 28, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

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

Soladek is marketed with claims that the product treats "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy." The product is sold in a box labeled in Spanish and containing a vial of the solution.

FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins.  Intake of excessively high levels of these vitamins poses a risk to human health.

The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.

Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.

Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately.  

Soladek cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA.  However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

Health care professionals and consumers should report adverse events or other problems with regulated products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.


Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@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. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Chester County Dairy
2. Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy
3. New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
4. Orkin Warns of Four Pests to Avoid this Fourth of July
5. FDA Warns Consumers about Counterfeit Alli
6. Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
7. Physicians Foundation Warns of Potential Impact From New Medicare Cuts Effective Today
8. H.E.A.T. Warns Drivers, Auto Dealers of Continuing Trend in Unconventional Auto Crimes
9. FDA Warns Users About Faulty Components in 14 External Defibrillator Models
10. FDA Warns About Fraudulent Tamiflu
11. FDA Warns Consumers to Avoid TimeOut Capsules
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Volumes: Global Analysis (United States, China, Japan, Brazil, United ... to their offering. ... healthcare business planners, provides surgical procedure volume data in ... with an in-depth analysis of growth drivers and inhibitors, ...
(Date:6/23/2016)... , June 23, 2016  The National ... has joined the health policy research organization as ... Romano , MD, senior vice president and chief ... company,s representative on the NPC Board of Directors. ... pleased that Mallinckrodt has joined us in support ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Investment Group (TGIG), has initiated cultivation and processing operations at its production facility, ... Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of proactive ...
(Date:6/24/2016)... ... 24, 2016 , ... Today, MTI-GlobalStem, a provider of optimized ... difficult to transfect cells, announces its launch of the PluriQ™ G9™ Gene Editing ... is a complete system for culturing and transfecting human pluripotent stem cells ...
(Date:6/24/2016)... ... June 24, 2016 , ... Southern Illinois University School ... for the Illinois State Dental Society (ISDS) Foundation’s Mission of Mercy (MOM). They ... Center in Collinsville. , They expect to treat approximately 2,000 patients ...
Breaking Medicine News(10 mins):