FDA: Permanent Injunction Entered Against Supplement Manufacturer Tied to Steroids

<p>FDA said Mira Health Products Ltd. informed the federal court in the Eastern District of New York that it has ceased operations and is no longer manufacturing, processing, packing, labeling, holding or distributing dietary supplements.</p>

WASHINGTON—A manufacturer of dietary supplements that is no longer in business and whose product contained anabolic steroids has been permanently enjoined from operating, FDA announced Wednesday.

The case was filed against Mira Health Products Ltd., a Farmingdale, N.Y.-based dietary supplement manufacturer, and two men that appear to be father and son (Michael S. Ragno and Michael S. Ragno, Jr.).

FDA said the company informed the federal court in the Eastern District of New York that it has ceased operations and is no longer manufacturing, processing, packing, labeling, holding or distributing dietary supplements.

About a year ago, FDA warned consumers to discontinue use of a product made by Mira that contained two potentially harmful anabolic steroids, methasterone, a controlled substance, and dimethazine.

Healthy Life Chemistry By Purity First B-500 was marketed as a Vitamin B dietary supplement.

Mira could not be immediately reached for comment. A number listed online for the dietary supplement manufacturer was out of service and the lawyer (Marc Ullman) who previously represented the company during the FDA investigation declined to comment.

On July 1, U.S. District Court Judge Joseph Bianco entered a consent decree for permanent injunction against the company. Mira cannot resume business until it receives written notice from FDA that its operations are compliant with the Federal Food, Drug and Cosmetic Act (FD&C) and all applicable regulations, according to the agency.

FDA last year warned consumers that it had received 29 incidents linking Mira’s product to such adverse effects as fatigue, muscle cramping and myalgia (muscle pain). The July 26, 2013 notice also disclosed that females using the product reported unusual hair growth and missing their menstruation while men who used it said they suffered impotence and low testosterone.

The company subsequently recalled dietary supplements that were made between June 1, 2010 and May 31, 2013, FDA said. 

According to public records, FDA last year cited Mira for nine “observations" or alleged violations of cGMPs (current Good Manufacturing Practices)—including failure to verify its finished batch of supplements met product specifications for identity, purity, strength and composition—following an inspection of its facility.

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