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Chart: FDA Recalls & Court Actions

This article was originally published in The Tan Sheet

Executive Summary

FDA Recalls & Court Actions



FDA Recalls & Court Actions

July 14, 2004

CLASS II

Bulk American Ginseng

648 mg capsules, containing 100% American Ginseng Powder (PANAX Ginseng Root). Product: American Ginseng Caps, Lot no. 034632, quantity: 13 m, product no. VS-2064. Important: This container is intended for BULK SHIPPING ONLY. The contents should be repacked WITHIN 90 DAYS into tightly closed containers. The manufacturer does not assume responsibility for any changes in physical appearance or potencies when these instructions are disregarded. -- Labeling for repacked product: The Vitamin Shoppe brand American Ginseng 648 mg, 100 CAPSULES, Herbal Supplement, Lot 169-1006-1021 EXP 10-2006. Bulk Product No. VS-2064, Bulk Lot No. 034632.

Manufacturer:

Nature's Value, Inc., Bay Shore, NY.

Recalled by:

Manufacturer, by letter on May 7, 2004. FDA-initiated recall is ongoing.

Distribution:

N.J.; 95,000 capsules.

Reason:

American Ginseng 648 mg capsules Bulk Lot No. 034632 were analyzed by SRL and found to be contaminated with pesticides.

Recall number:

F-276-4.

EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Tan Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation.

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