Year 2007 2006 2005 2004 2003 2002
U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 2003
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Biochem brand Ultimate Lo Carb Bar, Chocolate
Brownie Nut
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Labrada Nutrition brand Lean Body Hi Protein
Meal Replacement Bar - Cookies & Cream flavor
-
Mason Natural Chewable Calcium 600 with Vitamin
D
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Natural Treasures TMG
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Nature's Remedy Tablets (Sennosides, USP 8.6mg)
Stimulant Laxative
-
Nature's Remedy Tablets, (Cascara sagrada 150mg
and Aloe 100mg) Laxative
-
Re-Vita Liqua Health. Berry Flavored Dietary
Supplement (2)
-
Re-Vita Liqua Health. Butternut flavor Dietary
Supplement
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Re-Vita Liqua Health. Grape Flavored Dietary
Supplement (2)
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Re-Vita Liqua Health. Lemon-Lime Flavored Dietary
Supplement (2)
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Sundown Fish Oil 1000 MG
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Viga for Women tablets
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Viga Tablets (Naturalviagra) (2)
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VINAROL with VASX Tablets (2)
October 22, 2003
PRODUCT |
Mason Natural Chewable Calcium
600 with Vitamin D**Coffee Mocha Flavor tablet. A calcium/vitamin D supplement
in a tablet dosage form, packed in plastic bottles with a white, blue, red,
black and brown paper label. Recall # F-010-4. |
CODE |
Lot 0656N Exp. 10/2005, Lot 0793N
Exp. 12/2005. |
RECALLING FIRM/MANUFACTURER |
Mason Distributors, Inc, Hialeah,
FL, by letter on February 21, 2003. FDA initiated recall is complete. |
REASON |
Dietary Supplement is misbranded
in that it claims to be dairy free when it contains sodium caseinate, a
milk-derived ingredient. |
VOLUME OF PRODUCT IN COMMERCE |
2,866-100 tablet bottles. |
Distribution |
Nationwide. |
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September
10, 2003
PRODUCT |
VINAROL with VASX Tablets, 500mg,
blister packages of 2 or 7 tablets, Each tablet contains a proprietary blend
of Cassia Tree, Dodder Seed, Epimedium, Wolfbery, Saling, Cistanche, Mangolia
Vine Fruit, Red Raspberry, Narrow Leaved Polygala, Rehmannia Root, Eucommia
Bark, Hindo Lotus Seed, Bidemate Bark, Milk Vetch Seed, Cherokee Rose, Arborviate
Seed, American Ginseng, Ginkgo Biloba, Bionate International, Inc. Phoenix,
AZ. Recall # D-326-3. |
CODE |
Lot 030060 Exp 11/2006 thru 3/2007;
Lot 020245 Exp 11/2006 thru 3/2007. |
RECALLING FIRM/MANUFACTURER |
Bionate International, Inc., Scottsdale,
AZ, by press release on April 7, 2003, and by letters on May 27, 2003. Firm
initiated recall is ongoing. |
REASON |
Unapproved New Drug; product contains
undeclared prescription drug sildenafil. |
VOLUME OF PRODUCT IN COMMERCE |
1-6 million tablets. |
Distribution |
Nationwide. |
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September 10, 2003
PRODUCT |
a) Viga Tablets (Naturalviagra),
200 mg, 20 and 30 count bottles and sample packets of 4 tablets, Ingredients:Ginseng,
Oat straw, Melria puama, DHEA, Saw palmentto, Tribulus, Yohimbe, and Androstenedione,
Inc. Recall # D-324-3;
b) Viga for Women tablets, 20 count bottles, (Natural Stimulant), Ingredients:
Mauria Puama, Ginseng, Maca, Wild Yam, Damiana, L-Arginine, Dong Quai, Guarana,
Horny Goat Weed, and Macuna Prurions Extract. Recall # D-325-3. |
CODE |
Catalog numbers 10725 All Lots.
b) Catalog numbers 10728 All Lots. |
RECALLING FIRM/MANUFACTURER |
Best Life International Inc., Mayaguez,
PR, by letter on May 23, 2003. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; product contains
the undeclared prescription drug ingredient Sildenafil. |
VOLUME OF PRODUCT IN COMMERCE |
29,992 bottles. |
Distribution |
Puerto Rico. |
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September 10, 2003
PRODUCT |
a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count
bottles and 4 tablet sample packets, Each tablet contains: Ginseng-40mg,
Oat straw-10mg, Mauria puama-10mg, DHEA-10mg, Saw palmentto-40mg, Tribulus
terrestris-40mg, Yohimbe extract-40mg, and Androstenedione-10mg. Recall
# D-322-3;
b) Viga for Women tablets, BEST LIFE, 20 tablet bottles,Ingredients: Mauria
Puama, Ginseng, Maca, Wild Yam, Damiana, L-Arginine, Dong Quai, Guarana,
Horny Goat Weed, and Macuna Prurions Extract. Recall # D-323-3.
|
CODE |
All Codes. |
RECALLING FIRM/MANUFACTURER |
Recalling Firm: RMA Laboratories, Inc., Paramount,
CA, by press release on June 24, 2003, and by letters on May 12, 2003 through
July 8, 2003. Manufacturing Firm: Health Nutrition Inc., Torrance, CA. and/or
Best Life International, Inc. Firm initiated recall is ongoing. |
REASON |
Unapproved New Drug; product contains undeclared
prescription drug Sildenafil. |
VOLUME OF PRODUCT IN COMMERCE |
Approx. 6 million tablets. |
Distribution |
Nationwide. |
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August 13, 2003
PRODUCT |
Sundown Fish Oil 1000 MG Dietary
Supplement 120 Softgels Omega-3 Fatty Acids EPA/DHA Concentrate, packed
in plastic bottles with screw on plastic caps. Recall # F-483-3. |
CODE |
CODE Lot Number 357849. |
RECALLING
FIRM/MANUFACTURER |
Rexall Sundown, Boca Raton, FL,
by letter on April 8, 2002. Firm initiated recall is complete. |
REASON |
Product labeled as Fish Oil Capsules
consists in whole or in part of Vitamin E capsules. |
VOLUME OF PRODUCT IN COMMERCE |
35,000 120 capsule bottles. |
Distribution |
Nationwide. |
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May 14, 2003
PRODUCT |
Natural Treasures TMG Dietary Supplement,
Trimethylglycine-Homocystine Manager, 60 capsules. Recall # F-367-3. |
CODE |
Lot 001TMG9. |
RECALLING
FIRM/MANUFACTURER |
American Supplement Technologies,
Inc., Tempe, AZ, by letter on February 28, 2001. Firm initiated recall is
complete. |
REASON |
The dietary supplement contained
smaller amount of Vitamin B12 than listed on the label. |
VOLUME OF PRODUCT IN COMMERCE |
Undetermined. |
Distribution |
Nationwide. |
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March 26, 2003
PRODUCT |
a) Nature's Remedy Tablets, (Cascara
sagrada 150mg and Aloe 100mg) Laxative, 15, 30 and 60 count foil-backed
blistercard packages. Recall # D-174-3.
b) Nature's Remedy Tablets (Sennosides, USP 8.6mg) Stimulant Laxative, 15,
30, and 60 count foil-backed blistercard packages. Recall # D-175-3. |
CODE |
a) Lot Number/Exp. Date: M0013 exp.
3/03; M0014 exp.3/03; M0015 exp. 4/03; M0016 exp. 4/03; M0017 exp. 4/03;
M0018 exp. 4/03; M0019 exp. 4/03; M0020 exp. 4/03; M0021 exp. 4/03; M0023
exp. 4/03; M0024 exp. 4/03; M0025 exp. 4/03;M0026 exp. 4/03; M0028 exp.
4/03. 0022/TAX015 exp 4/03; 0029/TAZ016 exp. 4/03.
b) Lot No./Exp. Date: M 100133 1/03; M100133A 1/03; M103412 5/03; M103413
6/03; M103414 6/03; M106408 10/03; M106457 10/03; M106458 10/03; M106531
10/03; M106532 10/03; M200112 1/04; M200113 1/04; M200114 1/04; M201715
3/04; M201716 3/04; M201717 3/04; M202573 4/04; M202574 4/04; M202575 5/04;
M202576 5/04; M202577 5/04; M202578 5/04; M202579 5/04; M202580 5/04; M202580A
5/04; M202581 6/04; M203643 6/04; M203757 6/04; M203758 6/04; M203759 6/04;
M204427 7/04; M204427A 7/04; M204428 7/04; 140100637/LOT H MA/2003; 140103412/LOT
I MA/2003; 140200097/LOT J and LOT M200097 JA/2004; 140202576/LOT K MA/2004.
|
RECALLING FIRM/MANUFACTURER |
Glaxo Smith Kline, Parsippany, NJ,
by letters on January 23, 2003. Firm initiated recall is ongoing.
|
REASON |
a) Subpotent; active ingredient
(Aloe) (stability 12 month timepoint).
b) Superpotent; active ingredient (stability 12 month timepoint) |
VOLUME OF PRODUCT IN COMMERCE |
1,289,220 units. |
Distribution |
Nationwide and Canada. |
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March 26, 2003
PRODUCT |
Labrada Nutrition brand Lean Body
Hi Protein Meal Replacement Bar - Cookies & Cream flavor, Net. Wt. 78g,
single serve nutritional bar wrapped in flexible film. Recall # F-283-2. |
CODE |
Best by dates of 06/10/03 through
07/29/03. |
RECALLING
FIRM/MANUFACTURER |
Elan Nutrition, L.L.C., Grand Rapids,
MI, by letter on January 29, 2003. FDA initiated recall is ongoing. |
REASON |
Product contains undeclared almond
butter. |
VOLUME OF PRODUCT IN COMMERCE |
327,339 bars. |
Distribution |
Nationwide. |
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March 12, 2003
PRODUCT |
Biochem brand Ultimate Lo Carb Bar,
Chocolate Brownie Nut, wrapped in flexible foil-like film, Net wt. 60 g
(2.1 oz.).Recall # F-235-3. |
CODE |
UPC #15794-18809 with the following
lot numbers. APR1803S1, APR1803S6, APR1803W6, APR1803W1, APR1803H7, APR1803N6,
APR1903S7, APR1903N7 and APR1903W7. |
RECALLING
FIRM/MANUFACTURER |
Elan Nutrition, L.L.C., Grand Rapids,
MI, by press release, telephone and letter on January 17, 2003. FDA initiated
recall is ongoing. |
REASON |
Product may contain undeclared peanut
butter. |
VOLUME OF PRODUCT IN COMMERCE |
158,496 bars. |
Distribution |
Nationwide. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Lemon-Lime Flavored Dietary
Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One
Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16
oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic
bags with 10, 60, or 600 of these packets per bag). Each individual packet
is labeled in part: 'Re-Vita Liqua Health (Lemon-Lime) Not For Individual
Sale. See Master Packaging For Nutritional Information.' Recall # F-188-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL., by letter on December 13, 202. FDA initiated recall is ongoing. |
REASON |
The product contained an undeclared color, FD&C
Yellow No. 5. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Lemon-Lime Flavored Dietary
Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy
Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles
and 5 fl. oz. packets (packets further packaged in plastic bags with 10,
60, or 600 of these packets per bag). Each individual packet is labeled
in part: 'Re-Vita Liqua spirulina (Lemon-Lime) Not For Individual Sale.
See Master Packaging For Nutritional Information.' Recall # F-192-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL., by letter on December 13, 202. FDA initiated recall is ongoing. |
REASON |
The product contained an undeclared color, FD&C
Yellow No. 5. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined.
|
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Butternut flavor Dietary
Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy
Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles
and 5 fl. oz. packets (packets further packaged in plastic bags with 10,
60, or 600 of these packets per bag). Each individual packet is labeled
in part: 'Re-Vita Liqua Spirulina (Butternut) Not For Individual Sale. See
Master Packaging For Nutritional Information.' Recall # F-190-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL., by letter on December 13, 202. FDA initiated recall is ongoing. |
REASON |
The product contained an undeclared color, FD&C
Yellow No. 5. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Berry Flavored Dietary
Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One
Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16
oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic
bags with 10, 60, or 600 of these packets per bag). Each individual packet
is labeled in part: 'Re-Vita Liqua Health (Berry) Not For Individual Sale.
Recall # F-186-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL, by letter on December 13,2002. FDA initiated recall ongoing. |
REASON |
The product contained an undeclared color, FDC
Red #40. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Berry Flavored Dietary
Supplement labeled in part: 'Nutrients From Nature LIQUA Spirulina Energy
Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles
and 5 fl. oz. packets (packets further packaged in plastic bags with 10,
60, or 600 of these packets per bag). Each individual packet is labeled
in part: 'Re-Vita Liqua Spirulina (Berry) Not For Individual Sale. Recall
# F-189-3. |
CODE |
All codes are involved that do not list the
referenced color. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL, by letter on December 13,2002. FDA initiated recall ongoing. |
REASON |
Undeclared FDC Red #40. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Grape Flavored Dietary
Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One
Nutritional Assurance. The product is sold in 32 oz. plastic bottles, 16
oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic
bags with 10, 60, or 600 of these packets per bag). Each individual packet
is labeled in part: 'Re-Vita Liqua Health (Grape) Not For Individual Sale.
Recall # F-187-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL, by letter on December 13,2002. FDA initiated recall is ongoing. |
REASON |
The product contained an undeclared color, FDC
Red #40. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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February 19, 2003
PRODUCT |
Re-Vita Liqua Health. Grape flavor Dietary Supplement
labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster.
The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and
5 fl. oz. packets (packets further packaged in plastic bags with 10, 60,
or 600 of these packets per bag). Each individual packet is labeled in part:
'Re-Vita Liqua Spirulina (Grape) Not For Individual Sale. Recall # F-191-3. |
CODE |
All products on the market at the time the recall
was initiated. |
RECALLING FIRM/MANUFACTURER |
Re-Vita Manufacturing Co., Inc., Orange Park,
FL, by letter on December 13,2002. FDA initiated recall ongoing. |
REASON |
The product contained an undeclared color, FDC
Red #40. |
VOLUME OF PRODUCT IN COMMERCE |
To be determined. |
Distribution |
To be determined. |
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|