Recall -- Firm Press Release
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1 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... U.S. Food and Drug Administration back to Recalls, Market Withdrawals, & Safety Alerts Recall -- Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa Contact: Consumer: admin@iowaselectherbs.com FOR IMMEDIATE RELEASE September 15, 2015 Cedar Rapids, IA Iowa Select Herbs, LLC (the "Company") is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated. There are no reports to date of side effects or adverse events. The recalled products are herbal extracts marketed under the Iowa Select Herbs brand in either an alcohol or alcohol free (A/F) solution packaged in various sizes from 1oz to 1 gallon. The following lots are being recalled: 9:18:05 AM]
2 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... PRODUCT QUANTITY** LOT EXP. DATE CHAPARRAL /19 CILANTRO /20 CYPRESS L12 and /20 and 9/19 RASBEERRY and /20 and 12/19 SAGE and /20 and 12/19 WHITE WILLOW /20 ALISMA H040 2/19 ELDERBERRIES and /19 and 6/19 FENUGREEK /19 GOLDENSEAL /19 RHODIOLA H504 12/19 WHITE PEONY EXTRACT H209 2/20 YOHIMBE and /18 ST JOHNS WORT /19 PANAX GINSENG /19 PAPAYA LEAF CAPSULES 36 unknown unknown ZIZIPHUS GF 8/19 ACIA BERRY /17 ALFALFA /19 ALOE VERA 10 m /16 ARNICA FLOWERS /19 ARTICHOKE LEAF /17 ASHWAGANDA /19 ASTRAGULUS /19 ATRACTYLODES /17 BEET ROOT /19 BLACK COHOSH ROOT /19 BOSWELLIA SERRATA 2 209tc13 7/17 9:18:05 AM]
3 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... BROAD BEANS /18 BUCHU LEAF /17 CASCARA ROOT /17 CATS CLAW /19 CINNAMON BARK /19 CITRUS PEEL /19 CRANBERRY /17 CUDWEED /17 DAMIANA LEAF /17 FENNEL SEED EXTRACT /20 GINGER /19 GINGKO /18 GRAPESEED /19 GREEN TEA /19 HAWTHORNE BERRY /20 LOBELIA LEAF /19 MOMORDICA GALLON F 6/19 Nettle Leaf (4oz) /19 OREGANO /18 Organic Papaya Leaf 1 unknown unknown POMEGRANATE unknown PROPOLIS EXTRACT /18 PSOREALEA SEED /19 REISHI /20 RHUBARB ROOT /18 SANGRE DE GRADO /18 SARSPARILLA /19 SCHIZNDRA /18 9:18:05 AM]
4 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... TUMERIC /20 VALERIAN ROOT EXTRACT Mar 4/20 YARROW FLOWERS /18 PAPAYA LEAF EXTRACT (Various sizes) ; R1380ST; /20 Â BILBERRY /19 ACEROLA BERRY /19 ASTAGULUS ROOT /19 BAYBERRY /20 BILBERRY LEAF /19 BITTER MELON F 5/19 BLACK CURRANT /17 BLOOD ROOT /19 Burdock Root /20 Chamomile Flowers /19 CHICORY Root and /20 COLD BE GONE (Various Sizes) /20 Dandelion Leaf /20 DANDELION ROOT ; 32945; 20792; 33154; /20 and 9/19 DULSE LEAF /20 ECHINACEA PURP. (various sizes) /20 ELEUTHERO ROOT /19 GARCINIA FRUIT /19 GINGER ROOT and /19 Graviola Leaf /20 GYMNEMA SYLVESTRE 28 m /19 HIBISCUS /19 JERUSALEM ARTICHOKE /19 9:18:05 AM]
5 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... JEWEL WEED /19 JUNIPER BERRY /19 KAVA KAVA and /20 Lemon Balm Leaf /20 LICORICE ROOT and /20 MAGNOLIA BARK 2 PAS /20 and 5/19 Marshmallow Root /19 MILK THISTLE EXTRACT (various sizes) ; 32964; 631H /20 and 10/19; 10/19;1019 MUIRA PUAMA 22 R /20 NETTLE LEAF /19 OATSTRAW and /19 OATSTRAW EXTRACT and /19 OLIVE LEAF EXTRACT /19 Osha Root /20 Propolis Resin /18 Pygeum Bark /19 QUACK GRASS /19 Saw Palmetto Berry /19 Scullcap /19 SOLOMON SEAL and /19 SUMA ROOT /19 WORMSEED AN01 7/20 YUCCA ROOT /19 **Quantity refers to the number of units distributed and not the size of the unit (e.g. ounces or gallons). The recalled products were sold nationwide between January 1, 2015 to August 17, 2015 to wholesalers and consumers using the Company's website and through online marketplace websites, such as Amazon and Ebay. Iowa Select Herbs is notifying its wholesale and retail customers through written correspondence. We urge 9:18:05 AM]
6 Recalls, Market Withdrawals, & Safety Alerts > Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Feder... consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking these products. The Company is advising consumers to return the products to their place of purchase. Consumers may also return products directly to Iowa Select Herbs. Customers can call the Company at Monday through Friday from 9:00 am - 5:00 pm CST for instructions on the return and refund process. Any adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax: Online: Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the preaddressed form. Fax: FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. RSS Feed for FDA Recalls Information [what's this?] Photo: Product Labels ### Recalled Product Photos Are Also Available on FDA's Flickr Photostream. Page Last Updated: 09/15/2015 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility FDA Basics No FEAR Act Transparency Careers FOIA Site Map Website Policies 9:18:05 AM]
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