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
Cedar Rapids, IA (PRWEB) September 15, 2015 -- 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 (Photos of the recalled labels can be found here: http://store-vgtbh.mybigcommerce.com/content/Attachment%20B%20Product%20Labels.pdf):
PRODUCT QUANTITY** LOT EXP. DATE
Chaparral 2 31467 5/19
Cilantro 2 32446 4/20
Cypress 1 06305L12 & 6030542 4/20 and 9/19
Raspberry 1 19183 & 30614 4/20 and 12/19
Sage 1 32880 &32282 4/20 and 12/19
White Willow 2 32973 4/20
Alisma 1 130601H040 2/19
Elderberries 3 33223 and 19847 5/19 and 6/19
Fenugreek 39 32684 11/19
Goldenseal 3 32996 9/19
Rhodiola 1 131101H504 12/19
White Peony Extract 80 111001H209 2/20
Yohimbe 4 20508 and 32533 4/18
St Johns Wort 1 19892 2/19
Panax Ginseng 1 8958 12/19
Papaya Leaf Capsules 36 unknown unknown
Ziziphus 2 0515GF 8/19
Acia Berry 10 22345 5/17
Alfalfa 1 30464 2/19
Aloe Vera 10 m10752 11/16
Arnica Flowers 10 30599 2/19
Artichoke Leaf 10 45894 5/17
Ashwaganda 12 22349 5/19
Astragulus 1 30900 5/19
Atractylodes 10 45811 5/17
Beet Root 10 22351 8/19
Black Cohosh Root 2 19972 8/19
Boswellia Serrata 2 209tc13 7/17
Broad Beans 1 15882 11/18
Buchu Leaf 1 30338 7/17
Cascara Root 1 17233 3/17
Cats Claw 1 31487 4/19
Cinnamon Bark 3 29792 5/19
Citrus Peel 1 55756 4/19
Cranberry 1 76542 3/17
Cudweed 1 31796 3/17
Damiana Leaf 2 31265 4/17
Fennel Seed Extract 1 31001 4/20
Ginger 1 33500 5/19
Gingko 1 30520 8/18
Grapeseed 3 32574 2/19
Green Tea 1 32513 2/19
Hawthorne Berry 1 96483 2/20
Lobelia Leaf 1 31266 6/19
Momordica 1 58545F 6/19
Nettle Leaf 4 56598 5/19
Oregano 2 19976 5/18
Organic Papaya Leaf 1 unknown unknown
Pomegranate 1 15114217282 unknown
Propolis Extract 1 22386 8/18
Psorealea Seed 1 49697 2/19
Reishi 1 8427 2/20
Rhubarb Root 1 30176 2/18
Sangre De Grado 1 32900 2/18
Sarsparilla 1 30709 7/19
Schizndra 1 22389 7/18
Tumeric 1 37441 7/20
Valerian Root Extract 24 30772 4/20
Yarrow Flowers 24 22396 7/18
Papaya Leaf Extract 999 33161; R1380ST; 52972 4/20
Bilberry 1 19889 5/19
Acerola Berry 10 32795 4/19
Astagulus Root 13 31685 5/19
Bayberry 1 31186 4/20
Bilberry Leaf 10 19889 5/19
Bitter Melon 1 58545F 5/19
Black Currant 1 64832 5/17
Blood Root 1 30746 5/19
Burdock Root 24 20771 4/20
Chamomile Flowers 10 31778 3/19
Chicory Root 2 55426 and 55910 4/20
Cold Be Gone 300 87366 1/20
Dandelion Leaf 26 324966 9/20
Dandelion Root 21 30902; 32945; 20792; 33154; 33583 4/20 and 9/19
Dulse Leaf 2 22356 4/20
Echinacea Purp. 6 32263 4/20
Eleuthero Root 1 30469 12/19
Garcinia Fruit 4 21484 6/19
Ginger Root 22 31123 and 33500 5/19
Graviola Leaf 17 22363 9/20
Gymnema Sylvestre 28 m10866 2/19
Hibiscus 2 30763 3/19
Jerusalem Artichoke 24 5514 5/19
Jewel Weed 4 17544800916 5/19
Juniper Berry 2 19836 5/19
Kava Kava 29 30540 and 33660 2/20
Lemon Balm Leaf 12 32700 2/20
Licorice Root 130 32698 and 33380 2/20
Magnolia Bark 2 PAS130828 4/20 and 5/19
Marshmallow Root 3 30933 4/19
Milk Thistle Extract 113 32358; 32964; 631H42200122 4/20 and 10/19; 10/19
Muira Puama 22 R11165 1/20
Nettle Leaf 1 20769 5/19
Oatstraw 49 31953 and 33183 9/19
Oatstraw Extract 60 31953 and 33183 9/19
Olive Leaf Extract 42 32772 5/19
Osha Root 35 32303 3/20
Propolis Resin 1 22386 8/18
Pygeum Bark 39 32407 12/19
Quack Grass 2 20668 12/19
Saw Palmetto Berry 20 32654 9/19
Scullcap 3 32863 4/19
Solomon Seal 3 350150980313 and 32862 2/19
Suma Root 3 210535 2/19
Wormseed 25 0415AN01 7/20
Yucca Root 2 31990 2/19
**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 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 319-826-1000 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: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf. Mail to address on the preaddressed form.
• Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394259.htm
Gordon Freeman, Iowa Select Herbs, LLC, http://stores.iowaselectherbs.com/, +1 319-826-1000, [email protected]
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