Parker Waichman LLP

FDA Issues Soladex Vitamin Solution Warning

The U.S. Food and Drug Administration (FDA) just issued a warning to consumers to stop using Soladek Vitamin Solution due to the risk of serious health problems from dangerously high levels of vitamins A and D. The defective Soladek is a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic. Soladek is marketed […]

The U.S. Food and Drug Administration (FDA) just issued a warning to consumers to stop using Soladek Vitamin Solution due to the risk of serious health problems from dangerously high levels of vitamins A and D. The defective Soladek is a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic.

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.

The FDA recently received information that tested samples of Soladek, which 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 these symptoms should see a doctor immediately.

Soladek cannot 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: Online at https://www.accessdata.fda.gov/scripts/medwatch; by Regular Mail by using FDA postage paid form 3500 and mailing it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; by fax at: 800-FDA-0178; or by telephone at: 800-FDA-1088.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Mindy Gallagher
a year ago
5 Star Reviews 150
Nicole Copertino is the BEST. She is very knowledgeable and helpful. She give a clear understanding of your claim and takes the time to give a caring extra moment if u need it. Which means a lot.
NINA DEAN
2 weeks ago
5 Star Reviews 150
Very generous law firm. I personally want to Thank Jorge Peniche for introducing this firm and Francisco Albites for helping my family to get justice in a very complicated case. Thank you.
pinso ongmo
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038