TrimFast Group Inc. Voluntarily Agrees to FDA Recall of Revivarant Products Based Upon Safety Concerns Over `Blue Nitro' and Other Competitive Products
TrimFast Group Inc. (OTC BB:TRIMD) Thursday announced the voluntary recall of its proprietary Revivarant and Revivarant G dietary supplements.
The company was contacted by the Food and Drug Administration (FDA) late last week and was told the FDA was contemplating the recall of a product called "Blue Nitro" because of complaints of adverse side effects. TrimFast was advised that the recall might extend to all chemically related products, irrespective of concentration and recommended dosage, including Revivarant and Revivarant G.
To date, the company is not aware of any adverse side effects from the use of Revivarant or Revivarant G, nor has TrimFast Group received any complaints about the products.
The FDA action follows a report on Jan. 14 that California health and law officials warned about use of Blue Nitro as a recreational drug and asked retailers to voluntarily cease all sales of that product under the State's Controlled Substances Act of 1996. Dr. Jo Ellen Dyer, a pharmacist with the California Poison Control System, was quoted by CNN as having referred to eight reported poisonings during the last six months of 1998 that were linked to Blue Nitro.
"In the interest of compliance, we decided to move proactively," commented TrimFast Group's President and CEO Michael J. Muzio. "To our knowledge, the adverse reactions reported are based on Blue Nitro and possibly other related products, and we have received no complaints about Revivarant or Revivarant G; however, we thought it best to initiate a voluntary recall.
"We have only been selling these products for four months, and have only sold 200,000 units on a wholesale level. We intend to recall these products immediately, and foresee only a minor impact on our calendar 1999 revenues. Our focus is, and continues to be, on our core vitamin and herbal products business."
Part of the rapidly growing nutraceuticals industry, TrimFast Group is a formulator, manufacturer, distributor and marketer of innovative nutraceutical products for both the wholesale and retail channels.
The company's products are targeted to health- and fitness-conscious consumers under the brand names TrimFast Herbal Plus, Immune Blast, Max Impact, St. John's Wort, TrimFast, Sudden Energy, Ginseng Zing, HumaTropin AM, HumaTropin PM, MyoBlast, MyoBlast II and Kicks chewable children's multivitamins.
Management estimates current sales momentum could result in 1999 sales of approximately $10 million, which represents a potential 400% increase over 1998 revenues.
Statements included within this news release that are not historical in nature constitute forward-looking statements for the purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Investors are cautioned that this news release contains certain such forward-looking statements that involve substantial risks and uncertainties. When used, the words "anticipate," "believe," "estimate," "expect" and similar expressions as they relate to the company or its management are intended to identify such forward-looking statements. The company's actual results, performance or achievements could differ materially from the results expressed in, or implied by, these forward-looking statements. Further management discussion of risks and uncertainties can be found in the company's quarterly filing with the Securities and Exchange Commission and other periodic filings.
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CONTACT: TrimFast Group Inc., Tampa
Michael J. Muzio, 813/275-0050
or
Coffin Communications Group, Sherman Oaks, Calif.
Sanjay Sabnani, 818/789-0100
KEYWORD: FLORIDA CALIFORNIA
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