Navigation Links
FDA Warns Consumers to Stop Using Soladek Vitamin Solution

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.


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,
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:
(Date:11/25/2015)... DUBLIN , November 25, 2015 ... has announced the addition of the  ... 2015-2019"  report to their offering.  ... announced the addition of the  "Global ...  report to their offering.  ...
(Date:11/24/2015)... 24, 2015  Array BioPharma Inc. (Nasdaq: ... Officer, Ron Squarer , will present at ... York.  The public is welcome to participate in ... BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  , Ron ... 2015Time:1:30 p.m. Eastern Time Webcast: , ...
(Date:11/24/2015)... NEWS, Va. , Nov. 24, 2015  DILON ... they have signed an agreement for DILON to distribute ... geographies across the globe. The signing of this distribution agreement ... Discovery NM750b Molecular Breast Imaging system and is considered ... to provide better healthcare solutions for clinicians and their ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 2015 , ... The McHenry County law firm of Botto Gilbert Lancaster, ... Francisco J. Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented the claimant ... (2d) 130884WC. , According to court documents, Adcock testified that on May 10, 2010 ...
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a new Android ... The new app features a more intuitive SleepScore™ that rates sleep quality on a ... The SleepScore is created by a proprietary algorithm. Beddit analyzes the data to provide ...
(Date:11/25/2015)... ... ... Today, Mothers Against Drunk Driving (MADD) learned that the number ... first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol impaired ... Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in 2014. ...
(Date:11/25/2015)... ... 2015 , ... Privately owned Contract Development and Manufacturing Organization ... current state of the art research, development and manufacturing facility outside of Fort ... capacity as well as to support its clients’ growing research and development and ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... has focused on providing comprehensive solutions involving adult stem cell therapies to patients ... officially deemed the “Regenestem” name as a Registered Trademark (RTM). , Organizations are ...
Breaking Medicine News(10 mins):