Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients
[UPDATE 8/01/2013] - Purity First Health Products is recalling two lots of Healthy Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral (200 capsules) and all lot numbers for Healthy Life Chemistry Vitamin C (200 capsules). The B-50 capsules were found on testing by FDA to contain Methasterone (a schedule III controlled substance) and Dimethazine. Testing of the Multi-Mineral and Vitamin C capsules appear to indicate the presence of Dimethyltestosterone.
The following products are marketed as Dietary Supplements and are packaged in white plastic bottles:
- B-50, 100 capsule bottles, lot numbers F03Q and C02R
- Multi-Mineral, 200 capsule bottles, lot number 12-829
- Vitamin C, 200 capsule bottles, lot number E03Q
These recalled products were distributed nationwide via the internet, retail and through retail stores between July 2012 thru June 2013.
Immediately discontinue the use of this product and return it to the place of purchase.
AUDIENCE: Consumer, Health Professional
ISSUE: FDA is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.
BACKGROUND: The FDA has received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50. These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone.
RECOMMENDATION: Health care professionals are advised to ask their patients about any dietary supplements they may be using, particularly in patients exhibiting warning signs that may be associated with the use of steroids or steroid-like substances. These warning signs include liver injury, kidney failure and stroke. They also include hormone-associated adverse effects such as blood clots, including pulmonary embolism (a sudden blockage in a lung artery), and deep vein thrombosis (a blood clot that forms in a vein deep in the body, often in the lower leg or thigh). Consumers using Healthy Life Chemistry By Purity First B-50 who experience symptoms should consult a health care professional and report their experience to the FDA.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/31/2013 Firm Press Release - FDA]
[07/26/2013 Press Release - FDA]