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Wednesday, September 16, 2015

Iowa Select Herbs recalling various dietary suppliments

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:
PRODUCT
QUANTITY**
LOT
EXP. DATE
CHAPARRAL
2
31467
5/19
CILANTRO
2
32446
4/20
CYPRESS
1
06305L12 and 6030542
4/20 and 9/19
RASBEERRY
1
19183 and 30614
4/20 and 12/19
SAGE
1
32880 and 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 GALLON
1
58545F
6/19
Nettle Leaf (4oz)
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
31-Mar
4/20
YARROW FLOWERS
24
22396
7/18
PAPAYA LEAF EXTRACT (Various sizes)
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 (Various Sizes)
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. (various sizes)
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 (various sizes)
113
32358; 32964; 631H42200122
4/20 and 10/19; 10/19;1019
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:
Photo: Product Labels

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