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Posted November 21, 2012

Maker of Blood Pressure, Probiotic, Resveratrol and Hormonal Supplements Warned For Manufacturing Violations and Drug Claims

On November 2, 2012, the FDA issued a warning letter to Atrium, Inc. following a facility inspection which found a number of the company's dietary supplements to be adulterated or promoted as drugs.

ASPEN CHOLE-STERIN, Eversco Kalmz, chole-sterin supreme Red Yeast Rice, adreno medulla plus, and chole-sterin supreme Phyto Sterol Red Yeast Rice were found to be adulterated because they were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.

Atri-zinc chelate plus, atri k-chelate, atri cu-chelate, atri-cal chelate, atri mag chelate plus, aller-cal, glan-male plus, glyco-b, pineal plus, atri-acidic, hypothalamus 50, Nutripak CALCIUM CHELATE, Nutripak HYPOTHALAMUS 50 and Nutripak GLAND FEM were found to be adulterated because the company failed to maintain records required by federal regulations for products made from cattle.

In addition, dietary supplements ASPEN CHOLE-STERIN, resveratrol supreme, atri-probiotic supreme, Parasit-X, Glucobetic and ASPEN CALCIUM with Red Yeast Rice were found to be promoted as drugs on the company's websites.

For example, ASPEN CHOLE-STERIN contains red yeast rice and was promoted to lower cholesterol.

Resveratrol supreme contains resveratrol extract, grape seed extract, quercetin, pomegranate extract, mulberry fruit flower and phytosterols and was promoted for high cholesterol and cancer.

(See's Reviews of Red Rice Yeast Supplements, Resveratrol Supplements and Cholesterol-Lowering Supplements for tests of related products.)

Atri-probiotic supreme was promoted for digestive disorders.

(See's Review of Probiotic Supplements for tests of related products.)

Parasit-X contains a blend of herbs and enzymes including black walnut hulls, cloves, pumpkin seed, wormwood, grapefruit seed extract, Pau D'Arco, slippery elm, garlic, papain and bromelain. It was promoted to treat parasitic infections.

Glucobetic contains zinc, chromium, vanadyl sulfate, Gymnema sylvestre extract, bitter melon extract, and fenugreek extract. It was promoted to treat high blood sugar.

(See's Reviews of Chromium Supplements, Garlic Supplements, and Zinc Supplements for tests of related products.)

For more information on the FDA's warning letter, use the link below.