June 10, 2014 — The manufacturer of Healthy Life Chemistry by Purity First B-50, a dietary supplement that injured 29 people last year, has been hit with a lawsuit from the U.S. Food and Drug Administration (FDA) seeking to stop the company from marketing supplements.
The lawsuit (PDF) was filed in federal court in New York against Mira Health Products Ltd. and its chief operating officer, Michael S. Ragno. Inspectors from the FDA discovered numerous violations of current Good Manufacturing Practices (cGMP) standards, including failing to properly test ingredients or vet suppliers.
The FDA also found that Mira Health failed to verify that batches of their products were the proper identity, purity, strength, and composition. Furthermore, products were not stored in a way to prevent deterioration, contamination, or ingredient mix-ups.
The FDA warned:
“Although Defendants made some corrections in response to FDA’s inspection observations, they either did not follow through on their attempts to correct or failed to sustain the corrections they made, as shown by the ongoing, significant Dietary Supplement cGMP violations observed during the July 2013 inspection of the Defendants’ facility.”
Mira Health Supplements Linked to 29 Injuries
July 26, 2013 — The FDA is warning that consumers should not use Healthy Life Chemistry by Purity First B-50, a supplement manufactured by Mira Health Ltd.
The manufacturer claimed it sold a vitamin B-50 supplement, Multi-Mineral, and Vitamin C, their products actually contained methasterone and dimethazine, two harmful anabolic steroids. The FDA has received 29 reports of adverse events, including:
- Muscle cramping
- Myalgia (muscle pain)
- Abnormal laboratory findings for liver and thyroid function
- Abnormal cholesterol levels
- Females had unusual hair growth and missed menstruation
- Men had erectile dysfunction and low testosterone
Do I have a Dietary Supplement Lawsuit?
The Schmidt Firm, PLLC is currently accepting dietary supplement induced injury cases in all 50 states. If you or somebody you know has been injured by Healthy Life Chemistry by Purity First B-50, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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