| U.S. Food and Drug Administration |
FDA Consumer Alert P04-37, Mar 26, 2004
Aloe Commodities International, Inc., Recalls
Solutions IE Ageless Formula II Due to Excess Vitamin D
Aloe Commodities International, Inc., Carrollton, Texas, is recalling 1600
bottles of Solutions IE Ageless Formula II, Lot numbers P2207 and P2221 because
they contain a significantly higher-than-labeled level of vitamin D3.
(Approximately 188,640 International Units (IU) are present in each serving size
of 6 capsules instead of the intended level of 400 IU). The product is
distributed by Solutions International, Inc., Orem, UT.
The consumption of excess amounts of vitamin D may result in abnormally high
blood levels of calcium and urea. It may or may not result in high levels of
phosphorous. Initial symptoms of vitamin D toxicity are those associated with
hypercalcemia, weakness, fatigue, headaches, nausea, vomiting, diarrhea, mental
status changes and possibly coma in severe cases. Prolonged hypercalcemia
results in calcium deposits in soft tissues, which may result in hypertension
and may also result in heart rhythm abnormalities.
The recall was initiated after it was discovered that the product contained
more than the labeled amount of vitamin D due to an error in manufacturing. The
750 mg dietary supplement was packed 180 capsules per bottle and coded lot
number P2207 or P2221. The lot coding can be found on the bottom of the
bottle.
Solutions International Inc. reported three complaints received in the past
month of customers hospitalized for vitamin D toxicity with hypercalcemia.
The product was distributed by independent distributors nationwide. Consumers
who have purchased Solutions IE Ageless Formula II are urged to return it to
either Aloe Commodities International, Inc., 2161 Hutton Drive, Carrollton, TX.
75006 or Solutions International, 1272 South 1830 West, Orem, Utah 84058.
Consumers with questions can contact either Mark McKnight, President, Aloe
Commodities at 972-241-4251 or Brian Larson, President, Solutions International
at 801-785-4002.
This advisory was prepared by the FDA Office of Public Affairs.