Year 2007 2006 2005 2004 2003 2002
U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2002
- Acti-Gest tablets (labeled under numerous brands)
Spatz
brand
Natural
Products/ Natures Way brand
Full-O-Life
brand -Edson Farms Natural Foods brand
Clark's
Nutritional Centers brand
VP
Health Food brand
Nature's Concept The
Natural Choice brand
-
ARTHRIN Capsules, Joint and Tendon Formula
-
BotaniCleanse(R) Natural Cleansing Supplement Botanical Concentrates
- Dalyvite
Liquid, a Multi-vitamin Liquid distributed under the Hi-Tech label and Goldline
label.
-
Ferrous Sulfate Tablets, 325 mg. (Dietary Supplement) under the Eckerd, H.E.B., Longs, Nature's Valley, Sav-on
Osco by Albertson's and Ultima labels
- Health Ade Solutomic Bio-Available Vitamins
- HEPASTAT
capsules, Liver Formula
-
Hsu & Co. Brand, Super Enzymes
- Metabolife Diet & Energy bar with special Nutrition Formula, Contains Inulin, Green Tea Extract. Including flavors:
Lemony
Lemon, Yogurt Coated.
Downright
Chocolate, Chocolate Flavor Coated.
Perfectly Peanut, Chocolate Flavor Coated
Outrageous
Oatmeal Raisin, Yogurt Coated.
- Natural Oyster Shell Calcium 500 mg Tablets
- Nature's Plus(R) brand Complete Digestive Aid Digestive Enzyme Supplement
-
Nature's Plus(R) brand Dietary Supplement Betaine Hydrochloride
- Nature's
Plus(R) brand Maximum Strength Ultra-Zyme(R) Digestive Enzyme Supplement
-
Nature's Plus(R) brand Nature Cleanse(R)
- Nature's
Way Nettle Capsules
- NEUTRALIS
Capsules, Immune System Formula
- OA
PLUS Capsules, Joint and Tendon Formula
- OSPORO
Capsules, Skeletal Formula
- PC
SPES, Prostate Formula
- POENA
Capsules, Muscle and Tissue Formula
- Prostatin
Formula #103
- RASPES Capsules, Joint and Tendon Formula
-
Solgar's Digestive Aid (US Label) and Solgar's Digestive
Enzymes (UK Label)
-
SP Natural Peanut Butter Standard Bar, Multi-Vitamin Whole
Food Health Bar
-
SPES Capsules, Immune System Formula
-
Ultra Slim-Fast brand with Soy Protein Ready to Drink Liquid Shakes in 11.5
fl. oz. sizes:
Orange-Pineapple.
Apple-Cranberry-Raspberry.
Orange-Strawberry-Banana.
December 18, 2002
PRODUCT |
Natural Oyster Shell Calcium 500
mg Tablets in 100 count bottles. The product is shipped in cases that
contain 72 of the 100 count bottles.
The brand name of the product is Kaiser Permanente. Recall # F-095-3. |
CODE |
Lot #5235 exp. Jun 04. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Dixon Shane,
Inc., Philadelphia, PA, by telephone on November 19, 2001.
Manufacturer: Vicen Nutritional, Swedesboro, NJ. Firm initiated recall
is complete |
REASON |
The product was manufactured under
conditions whereby it may have been cross-contaminated with amoxicillin. |
VOLUME OF PRODUCT IN COMMERCE |
5436 bottles. |
Distribution |
CA and OR. |
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December
18, 2002
PRODUCT |
Health
Ade Solutomic Bio-Available Vitamins in 1 quart bottles. Recall # F-102-3. |
CODE |
9315501 exp 12/01. |
RECALLING
FIRM/MANUFACTURER |
Eniva Corporation, Blaine, MN,
by telephone beginning on July 20, 2001.
Firm initiated recall is complete. |
REASON |
The product appeared to be spoiled
(product was clumpy and bottles swollen). |
VOLUME OF PRODUCT IN COMMERCE |
1100 - 32 fluid ounce bottles. |
Distribution |
Nationwide. |
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August 7, 2002
PRODUCT |
RA SPES Capsules, Joint and Tendon
Formula, 30 Capsules,
300 mg each, Herbal Dietary Supplement. Recall # D-363-2;
OA PLUS Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall #. D-364-2;
HEPASTAT Capsules, Liver Formula, 90 capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-365-2;
NEUTRALIS Capsules, Immune System Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-366-2;
OSPORO Capsules, Skeletal Formula, 30 Capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-367-2;
POENA Capsules, Muscle and Tissue Formula, 30 capsules, 300 mg each,
Herbal Dietary Supplement. Recall # D-368-2;
ARTHRIN Capsules, Joint and Tendon Formula,
30 capsules, 300 mg each, Herbal Dietary Supplement. Recall
# D-369-2. |
CODE |
All codes. |
RECALLING
FIRM/MANUFACTURER |
Botanic Lab, Brea, CA, by letter
on May 24, 2002. Firm initiated recall is ongoing. |
REASON |
Products contain various amounts
and combinations of undeclared prescription drug ingredients-Alprazolam,
Indomethacin, Ethinyl Estradiol, and/or DES. |
VOLUME OF PRODUCT IN COMMERCE |
Unknown. |
Distribution |
Nationwide and Internationally. |
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July 24, 2002
PRODUCT |
Nature's Way Nettle capsules,
100 count bottles. Recall # F-651-2.
|
CODE |
Product Code 15150; Lots Numbers
are 131237, 131238, 140738, and 215229. |
RECALLING
FIRM/MANUFACTURER |
Nature's Way Springville, UT,
by letter on June 20, 2002. Firm initiated recall is ongoing. |
REASON |
Nettle capsules contain elevated
amounts of lead. |
VOLUME OF PRODUCT IN COMMERCE |
40,409 /100 count bottles. |
Distribution |
Nationwide and Canada, Jamaica,
New Zealand, Panama, and Saudi Arabia. |
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June 26, 2002
PRODUCT |
Dalyvite Liquid, a Multi-vitamin
Liquid packed in brown, plastic bottles, One Pint (473 mL).
Product was distributed under the Hi-Tech label; Goldline
label. Recall # F-541-2. |
CODE |
Lot 101624, expiration date 2/2003
Hi-Tech NDC 50383-624-16;
Goldline NDC 0182-6151-40. |
RECALLING
FIRM/MANUFACTURER |
Hi-Tech Pharmacal Co., Inc.,
Amityville, NY, by telephone and letter beginning
March 7, 2002. Firm initiated recall is ongoing. |
REASON |
The product is contaminated with
yeast, & complaints of swollen containers were
received. |
VOLUME OF PRODUCT IN COMMERCE |
15,413 - 1 pint bottles. |
Distribution |
NY, CA, IL, NC, KY, OH, PA, IN,
NJ and Puerto Rico. |
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May 29, 2002
PRODUCT |
SP Natural Peanut Butter Standard
Bar, Multi-Vitamin Whole Food Health Bar, Net Wt 1.75 ounces. Recall #
F-444-2. |
CODE |
“Best Before Jul 26, 02,” “Best
By Jul 31, 02” or “Best By Nov 20, 02” on the bar wrappers. The
recalled 18-bar boxes have batch numbers of 1299,1304, 0r 2051 on the
bottom of the boxes. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Standard
Process, Inc., Palmyra, WI, by letter on April 19, 2002.
Manufacturer: Elan Nutrition (Formerly Five Star Brands) Grand Rapids,
MI. Firm initiated recall is ongoing. |
REASON |
The labels do not list sesame
seeds or extra virgin olive oil, which are contained in the product. |
VOLUME OF PRODUCT IN COMMERCE |
3362 boxes (18 bars each). |
Distribution |
Nationwide. |
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May 15, 2002
PRODUCT |
Ultra Slim-Fast brand with Soy
Protein Ready to Drink Liquid Shakes in 11.5 fl.
oz. sizes:
(a) Orange-Pineapple. Recall # F-397-2;
(b) Apple-Cranberry-Raspberry. Recall # F-398-2; (c) Orange-Strawberry-Banana. Recall # F-399-2.
|
CODE |
“BEST BY” dates affected: JANUARY 2002 FEBRUARY 2002 MARCH 2002. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Slim-Fast Foods
Co, (a Unilever Co.), West Palm Beach, FL,
by telephone, e-mail and fax beginning on February 13, 2001 and by letters
on February 14, 2001. Manufacturer: Kagome, Inc., Slim-Fast Foods Co.,
Los Banos, CA.
Firm initiated recall is complete. |
REASON |
Products are contaminated with
butyric acid anaerobes, resulting in sour taste
and swollen cans. |
VOLUME OF PRODUCT IN COMMERCE |
13,896,864 cans. |
Distribution |
Nationwide and Internationally. |
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May 1, 2002
PRODUCT |
PC SPES, Prostate Formula, Herbal
Dietary Supplement, 60 capsules, 320 mg each, over-the-counter sales.
Recall # D-198-2. Indicated for "prostate health" claim.
An herbal dietary supplement containing Chinese herbs (Reishi, Baikal
Skullcap, Rabdosia, Dyer's Woad, Mum, Saw Palmetto, San-Qi Ginseng, Licorice). |
CODE |
All lots and all codes. |
RECALLING
FIRM/MANUFACTURER |
International Medical Research,
dba Botanic Labs Inc., Brea, CA, by letter dated
February 8, 2002. State initiated recall is ongoing.
|
REASON |
The product contains the undeclared
prescription drug; Warfarin |
VOLUME OF PRODUCT IN COMMERCE |
Unknown. |
Distribution |
Nationwide and Internationally. |
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March 6,
2002
PRODUCT |
SPES capsules, Herbal Dietary
Supplement, Immune System Formula, 30 capsules per bottle, 300 mg each,
containing 15 different herbs.
Recall # D-196-2. |
CODE |
Lot 5311214 distributed from
8/9/2001 to 1/8/2002;Lot 5431249 distributed from 10/25/2001 to 1/8/2002. |
RECALLING
FIRM/MANUFACTURER |
Botanic Lab Brea, CA, by letters
on January 28, 2002. Firm initiated recall's ongoing. |
REASON |
Product contains the undeclared
prescription drug alprozolam. |
VOLUME OF PRODUCT IN COMMERCE |
Undetermined |
Distribution |
Nationwide and internationally. |
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February 6, 2002
PRODUCT |
a) Hsu & Co. brand, Super
Enzymes, 60 & 120 & 180 tablets,
Recall # F-280-2; b) Hsu & Co. brand, Super
Enzymes, 60 & 180 capsules,
Recall # F-281-2;
c) Acti-Gest tablets (labeled under numerous brands) -Spatz brand, 90 tablets. -Natural Products/ Natures Way brand, 180 tablets. -Full-O-Life brand, 90 tablets. -Edson Farms Natural Foods brand, 90 & 180 tablets. -Clark's Nutritional Centers brand, 90 tablets. -VP Health Food brand, 90 & 180 tablets. -Nature's Concept The Natural Choice brand, 60 & 90
& 180 tablets.
Recall # F-282-2. |
CODE |
a) Lots 0050203 & 0090203;
b) Lots 0050203 & 0090203;
c) Lot 5800204;
Lot 5800204;
Lot 5800204;
Lot 5800204;
Lot 5800204;
Lot 5800204;
Lot 5800204. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Licata Enterprises,
Huntington Beach, CA, by telephone and fax on May 16, 2001.
Manufacturer: Horizon Laboratories, Chatsworth, CA.
Firm initiated recall is ongoing. |
REASON |
Salmonella contamination of raw
material Pepsin. |
VOLUME OF PRODUCT IN COMMERCE |
173,702 tablets, 95,008 capsules.
|
Distribution |
CA, OH and MI. |
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January 30, 2002
PRODUCT |
Metabolife Diet & Energy
bar with special Nutrition Formula, Contains Inulin,
Green Tea Extract.
Including flavors:
1) Lemony Lemon, Yogurt Coated. Recall #F-144-2;
2) Downright Chocolate, Chocolate Flavor Coated. Recall # F-145-2
3) Perfectly Peanut, Chocolate Flavor Coated. Recall # F-146-2;
4) Outrageous Oatmeal Raisin, Yogurt Coated. Recall # F-147-2.
All bars are Net Weight 2 Oz. (56.8 g) |
CODE |
Best buy dates 2/16/02 and earlier. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Metabolife International,
San Diego, CA, on May 9, 2001 via press release followed by faxed letters and emails. Manufacturer:MLO Products Fairfield, CA. Firm
initiated recall is complete. |
REASON |
The products contained excessive
amounts of Vitamin A. |
VOLUME OF PRODUCT IN COMMERCE |
4,917,216 bars. |
Distribution |
Nationwide |
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January 16, 2002
PRODUCT |
US Label: Solgar's Digestive
Aid, Dietary Supplement
UK Label: Solgar's Digestive Enzymes
Israeli Label: Solgar's Digestive Aid
French Label: Solgar's Digestive Enzymes
Tablets packaged in plastic bottles of 100's.
Recall # F-114-2. |
CODE |
Lot 31993 and 30957 |
RECALLING
FIRM/MANUFACTURER |
Solgar Vitamin and Herb Leonia,
NJ, by letter 4/25/01, FDA issued a press release on 4/27/01. Firm
initiated recall complete. |
REASON |
The product was manufactured using
pepsin that American Laboratories, Inc. recalled due to Salmonella contamination. |
VOLUME OF PRODUCT IN COMMERCE |
754 bottles |
Distribution |
Nationwide and UK, South Africa,
France, Ireland, and Israel. |
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January 16, 2002
PRODUCT |
1) Nature's Plus(R) brand Nature
Cleanse(R) BotaniCleanse(R) Natural
Cleansing Supplement Botanical Concentrates, Green Foods & Vitamin
C, 90 tablets per bottle, Product No. 1138; Recall # F-115-2; 2) Nature's Plus(R) brand Complete Digestive
Aid Digestive Enzyme Supplement, 90 tablets per bottle, Product No. 4450. Recall # F-116-2;
3) Nature's Plus(R) brand Maximum Strength Ultra-Zyme(R) Digestive
Enzyme Supplement The Ultimate Digestive Aid a) 90 tablets per bottle,
Product No. 4452. b) 180 tablets per bottle, Product No. 4453. c) Italian label Nature's Plus(R) brand
Enzimi Alimentari Ultra- Zyme(R)Bioalimento 90 Tavolette
Peso netto 75g
Prodotto Numero E0 4452
01. Recall # F-117-2;
4) Nature's Plus(R) brand Dietary Supplement Betaine Hydrochloride
600 mg, 90 tablets per bottle, Product No. 4370. Recall # F-118-2. |
CODE |
Firm on labels - Manufactured
with LOVE by
Natural Organics Laboratories,Inc.,
makers of Nature's Plus Amityville,
New York U.S.A. NATURAL ORGANICS, Inc.(TM)Codes:
Product Name Product #
Lot #s
Nature Cleanse 1138 008597
BotaniCleanse
Betaine Hydrochloride 4370
1006874
Digestive Enzyme 4450
1008884
Ultra-Zyme 90 tabs 4452
1007110
1005942
1009520
1007562
Ultra-Zyme 180 tabs 4453 1005943
1007116
1009596
1006906
Ultra-Zyme Bioalimento 4452 01 1009034 |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Natural
Organics, Inc. Melville, NY, by press release and letter on May 8, 2001,
Manufacturer: Natural Organics Laboratories, Inc. Amityville,
NY.
FDA initiated recall is ongoing. |
REASON |
The products were manufactured
using pepsin that American Laboratories, Inc., recalled due to Salmonella
contamination. |
VOLUME OF PRODUCT IN COMMERCE |
BotaniCleanse: 1802 bottles;
Digestive Enzyme:1461 bottles; Betaine HCl: 1771 bottles; Ultra-Zyme:
9626 bottles (90 tabs), 7446 (180 tabs), & 150 bottles (productto Italy). |
Distribution |
Nationwide and International.
The Ultra-Zyme Italian labeled product was sold to a sole distributor account in Italy. |
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January 16, 2002
PRODUCT |
Ferrous Sulfate Tablets, 325 mg. (Dietary Supplement) under the Eckerd, H.E.B., Longs, Nature's Valley, Sav-on Osco by Albertson's and Ultima labels. The product is packed in 60 and 100 tablet blister strips in a carton,
Recall # F-120-2. |
CODE |
Lot Numbers OD01649, OF02547, OMB0627, OM02553,
OM03538, OD01649, OF02547, OH02400, 1CA2142, OH02400, OMB0628, OF02546,
OMB1226, OKB1115, OMB0629. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Leiner Health
Products, Inc. Carson, CA, by letter on May 16, 2001. Manufacturer: Leiner Health Products, Inc. Fort Mill, SC. Firm initiated recall
is complete. |
REASON |
The product is misbranded since it lists
an incorrect tablet strength on the inner blister packs. |
VOLUME OF PRODUCT IN COMMERCE |
130,380 cartons. |
Distribution |
Nationwide. |
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January 9, 2002
PRODUCT |
Prostatin Formula #103, 500 mg
capsules, 30 & 90 capsule bottles, Recall # F-110-2. |
CODE |
All lots and codes. |
RECALLING
FIRM/MANUFACTURER |
Recalling Firm: Herbal Doctor Remedies,
Monterey Park, CA, by letter dated 03/07/01.
Manufacturer: Sheng Chang Pharmaceutical Co Ltd., Taipei Hsein, Taiwan.
Firm initiated recall is complete.
|
REASON |
Product contains aristolochic acid, a potent carcinogen
and nephrotoxin.
|
VOLUME OF PRODUCT IN COMMERCE |
5/30 capsule and 2/90 capsule
bottles only. |
Distribution |
AZ, KY, PA and the Philippines. |
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|