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:2/12/2016)...  Eli Lilly and Company (NYSE: LLY ) today ... disodium) vitamin regimen patent would not presently be infringed by ... , Italy and ... with dextrose solution.  --> ... Appeal held that Lilly,s patent would be indirectly infringed by ...
(Date:2/12/2016)... 12 2016  OMS Supply, a large provider of ... announced today the recent launching of their new company ... of features that enhance the user experience and enable ... --> --> Despite ... company that started in early 2016, they have already ...
(Date:2/12/2016)... LOUISVILLE, Ky. , Feb. 12, 2016 ... it has completed a $47.1 million Series ... investors Cormorant Asset Management, Hillhouse Capital Group ... investors Morningside Venture Investments, AJU IB Investment, ... will be used to further advance clinical ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... 13, 2016 , ... Christie Medical Holdings, Inc. presented the ... VeinViewer® Vision vein finder for the nursing school simulation lab. This ... draw blood, combining technology with traditional technique. , “VeinViewer is a wonderful new ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi , a ... Providers list for its expertise in eClinical Solutions. DDi has built its solution ... technology needs of global clients. DDi provides smarter technology for Clinical Development, Regulatory ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to the Future , Feb. ... , As Winston Churchill said, “Those who don’t learn from history are doomed to repeat ... when they come knocking this year. But that takes time. , Take a close ...
(Date:2/12/2016)... Angeles, CA (PRWEB) , ... February 12, 2016 , ... ... With a hectic schedule, a demanding job, and no time to decompress, Rabinowitz found ... she dedicated herself to meditation for its impact on her life, implementing a 20-minute-per-day ...
Breaking Medicine News(10 mins):