14 Hydroxycut products recalled, FDA warns consumers to immediately stop use

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FDA recall press release:

FDA News

FOR IMMEDIATE RELEASE
May 1, 2009
Media Inquiries:
Susan Cruzan, 301-796-4540
Consumer Inquiries:
888-INFO-FDA


FDA Warns Consumers to Stop Using Hydroxycut Products


Dietary Supplements Linked to One Death; Pose Risk of Liver Injury

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut H ardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut H ardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut H ardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: 800-FDA-0178
–Phone: 800-FDA-1088

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
For more information:
Hydroxycut Products

Dietary Supplements -- Overview
FDA 101: Dietary Supplements
NIH Office of Dietary Supplements

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Iovate's recall press release:

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.

Iovate Health Sciences U.S.A., Inc. Voluntarily Recalls Hydroxycut-Branded Products

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 1, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is voluntarily recalling Hydroxycut branded products sold in the United States.

Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis. On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent thirdparty experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.

The recalled products are sold in multiple-count caplet and capsule boxes and bottles. The FDA advisory states that, “Consumers who have these products are urged to stop using them.” Iovate is working with the FDA and retailers to ensure that these products are quickly and effectively removed from the market. For product refunds, consumers are directed to return their product directly to the location where it was purchased. Consumers with questions about the advisory or recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 between 9 am and 5 pm Eastern Standard time.

The list of products being voluntarily recalled by Iovate:

HYDROXYCUT RAPID RELEASE REGULAR CAPLETS
631656893649 Hydroxycut 140ct Cap US
631656833621 Hydroxycut 60 GNC US
631656600988 Hydroxycut 300ct Caplets US
631656890129 Hydroxycut 36ct Cap US "with CARDS"
631656282245 Hydroxycut 160ct Cap US *Discontinued*
631656873214 Hydroxycut 58ct Cap US
631656813418 Hydroxycut 70ct Cap US
631656808612 Hydroxycut 70ct Caps US *Discontinued*
631656808117 Hydroxycut 100 cap US *Discontinued*
631656818642 Hydroxycut 140ct Cap US *Discontinued*
631656882414 Hydroxycut 80ct Caps US *Discontinued*
631656843262 Hydroxycut 210ct Cap US
631656828665 Hydroxycut 210 cap US *Discontinued*
631656600582 Hydroxycut 60ct + 1 Hydroxycut Sachet WB US
631656600476 Hydroxycut 72ct + Hydroxycut Sachet WB US
631656600483 Hydroxycut 100ct Caplets US
631656600506 Hydroxycut 150ct Caplets US
631656601251 Hydroxycut 170 Caplets US
631656600452 Hydroxycut 30ct Caplets US

HYDROXYCUT ******** LIQUID CAPSULES
631656600650 Hydroxycut ******** 120ct US
631656600834 Hydroxycut ******** 210ct US
631656001778 Hydroxycut ******** 30ct US
631656601435 Hydroxycut ******** 252ct US
631656601848 Hydroxycut ******** 30ct US Trial - Bodybuilding.com
631656601749 Hydroxycut ******** 120ct US NEW
631656601763 Hydroxycut ******** 252ct US
631656601756 Hydroxycut ******** 210ct US NEW

HYDROXYCUT CAFFEINE-FREE CAPLETS
631656801224 Hydroxycut Caffeine Free 140ct Cap US
631656821246 Hydroxycut Caffeine Free 330ct Cap US
631656801217 Hydroxycut Caffeine Free 100ct Cap US
631656801231 Hydroxycut Caffeine Free 58ct Cap US
631656899122 Hydroxycut Caffeine Free 36ct Cap US
631656600544 Hydroxycut Caffeine Free 60ct US
631656600551 Hydroxycut Caffeine Free 72ct US
631656600568 Hydroxycut Caffeine Free 100ct US

HYDROXYCUT MAX CAPLETS
631656601466 Hydroxycut Max 120ct bonus + 1Hyd Max Sachet WB US
631656601633 Hydroxycut Max 210ct Bonus + 1 Hyd Max Sachet WB US

HYDROXYCUT REGULAR DRINK PACKET
631656860191 Hydroxycut Weight Loss Drink Mix 21pk Sachet - Wild Berry US
631656860313 Hydroxycut Weight Loss Drink Mix 21pk Sachet - Country Lemonade US

HYDROXYCUT ******** DRINK PACKET (IGNITION STIX)
631656701326 Hydroxycut ******** Drink Mix 2.7g Sachet - Blue Raspberry US
631656701319 Hydroxycut ******** Drink Mix 2.6g Sachet - Fruit Punch US
631656760118 Hydroxycut ******** Drink Mix 40pk x 2g Sachet - Fruit Punch US
631656760125 Hydroxycut ******** Drink Mix 40pk x 2g Sachet - Blue Raspberry US

HYDROXYCUT CAFFEINE-FREE DRINK PACKET
631656760095 Hydroxycut Caffeine Free Drink Mix 21pk x 3.6g Sachet - Raspberry Ice US

HYDROXYCUT MAX DRINK PACKET
631656860375 Hydroxycut Max Drink Mix 40pk x 2.4g Sachet - Wild Berry US
631656860382 Hydroxycut Max Drink Mix 40pk x 2.7g Sachet - Lemonade US

HYDROXYCUT LIQUID SHOT
631656800159 Hydroxycut Weight Loss Single Shot 2oz - Wild Berry US
631656860207 Hydroxycut Weight Loss Shot 2 x 2oz Pk - Wild Berry US
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US

HYDROXYCUT MAX AQUA SHED
631656601855 Hydroxycut Max Aqua Shed 60ct Capsules US

HYDROXYCUT H ARDCORE RTD
631656860436 Hydroxycut H ardcore 4 x8oz RTD - Grape Infusion US
631656860399 Hydroxycut H ardcore 4 x 8oz RTD - Triple WildBerry US
631656860665 Hydroxycut H ardcore 12-pack RTD - Grape Infusion US
631656860467 Hydroxycut H ardcore 3 x 4-pack RTD - Grape Infusion US
631656860443 Hydroxycut H ardcore 3 x 4-pack RTD - Triple Wildberry US
631656860443 Hydroxycut H ardcore 3 x 4-pack RTD - Triple Wildberry US
631656860568 Hydroxycut H ardcore 12-pack RTD - Triple Wildberry US

HYDROXYCUT 24
631656600933 Hydroxycut 24 (96 caps/ blister pack) US

HYDROXYCUT CARB CONTROL
631656800036 Hydroxycut Carb Control 58ct Cap US
631656800029 Hydroxycut Carb Control 100ct Cap US
631656800012 Hydroxycut Carb Control 140ct Cap US

HYDROXYCUT NATURAL
631656600889 Hydroxycut Natural 100ct US

Please note that Hydroxycut Hoodia and Hydroxycut Cleanse products are not included in this recall; nor are any other Iovate products.

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...and thirteen more Hydroxycut products to add to their heap of recalled diet supplements:

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.

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

The UPC numbers being added to the May 1 list are as follows:

631656800265 Hydroxycut Hard core 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hard core 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hard core Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets

Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis. On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.

Consumers with questions about the recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 Monday through Friday between 9 am and 5 pm Eastern Daylight Time.

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FDA class II recall still in progress:

PRODUCT
1) HYDROXYCUT - Lose Weight Fast - DIETARY SUPPLEMENT -RAPID RELEASE CAPLETS - Distributed under the Iovate and/or MuscleTech brand names in the following sizes and UPC codes: -- HYDROXYCUT 30 RAPID RELEASE CAPLETS, UPC 631656600452 (US); -- HYDROXYCUT 36 count CAPLETS "with CARDS", UPC 631656890129 (US); -- HYDROXYCUT 58 count CAPLETS, UPC 631656873214 (US); -- HYDROXYCUT 60 GNC, UPC 631656833621 (US); -- HYDROXYCUT 60 RAPID RELEASE CAPLETS (with or without + 1 FREE Hydroxycut Drink Packet Inside (Sachet WB), UPC 631656600582 (US); -- HYDROXYCUT 60 RAPID RELEASE CAPLETS, UPC 631656500585; -- HYDROXYCUT 70 count CAPLETS, UPC 631656813418 (US); -- HYDROXYCUT 72 RAPID RELEASE CAPLETS (with and without + FREE Hydroxycut Drink Packet Inside (Sachet WB), UPC 631656600476 (US); -- HYDROXYCUT 100 RAPID RELEASE CAPLETS, UPC 631656600483 (US); -- HYDROXYCUT 140 count CAPLETS, UPC 631656893649 (US); -- HYDROXYCUT 150 RAPID RELEASE CAPLETS, UPC 631656600506 (US); -- HYDROXYCUT 170 RAPID RELEASE CAPLETS, UPC 631656601251 (US); -- HYDROXYCUT 210 RAPID RELEASE CAPLETS, UPC 631656843262 (US); -- HYDROXYCUT 300 count CAPLETS, UPC 631656600988 (US); -- HYDROXYCUT 100 count - 6 month supply (7 bottles+ 4 free) Kit , UPC 631656000658; -- HYDROXYCUT 2 x 60 count Club Pack Kit, UPC 631656600896 (US); -- HYDROXYCUT 160 count Caplets, UPC 631656282245 (US) *Discontinued*; -- HYDROXYCUT 70 count Caplets, UPC 631656808612 (US) *Discontinued*; -- HYDROXYCUT 100 count Caplets, UPC 631656808117 (US) *Discontinued*; -- HYDROXYCUT 140 count Caplets, UPC 631656818642 (US) *Discontinued*; -- HYDROXYCUT 80 count Caplets, UPC 631656882414 (US) *Discontinued*; -- HYDROXYCUT 210 count caplets, UPC 631656828665 (US) *Discontinued*; -- HYDROXYCUT 100 count - 1 month supply (1 bottle+1 free) Kit, UPC 631656000672 *Discontinued* -- HYDROXYCUT 58 cap 12-pack Target Kit (US), UPC 631656874693 *Discontinued*; -- HYDROXYCUT 100 count - 3 month supply (4 bottles+2 free) Kit, UPC 631656000665 *Discontinued*; -- HYDROXYCUT 280 count -3 Pak Kit, UPC 631656001501 *Discontinued*; -- HYDROXYCUT 280 count -6 Pak Kit, USPC *Discontinued*. Recall # F-347-9;
2) Caffeine-Free HYDROXYCUT Weight-Loss Formula - RAPID RELEASE CAPLETS - DIETARY SUPPLEMENT - Distributed under the Iovate and/or MuscleTech brand names in the following sizes and UPC codes: -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 36 count Caplets, UPC 631656899122 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 58 count Caplets, UPC 631656801231 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 60 RAPID RELEASE CAPLETS or 60 CAPLETS, UPC 631656600544 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 72 CAPLETS or 72 RAPID RELEASE CAPLETS, UPC 631656600551 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 100 RAPID RELEASE CAPLETS, UPC 631656600568 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 100 count Caplets, UPC 631656801217 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 140 count Caplets, UPC 631656801224 (US); -- Caffeine-Free HYDROXYCUT Weight-Loss Formula 330 count Caplets, UPC 631656821246 (US). Recall # F-348-9;
3) HYDROXYCUT ******** - LIQUID CAPSULES - DIETARY SUPPLEMENT - Distributed under the Iovate and/or MuscleTech brand names in the following sizes and

UPC codes: -- HYDROXYCUT ********, 30 Liquid Capsules, UPC 631656001778 (US); -- HYDROXYCUT ********, 30 Liquid Capsules, UPC 631656601848 (US Trial); -- HYDROXYCUT ********, 120 Liquid Capsules, UPC 631656600650 (US); -- HYDROXYCUT ********, POWERFUL NEW FORMULA, 120 Liquid Capsules, UPC 631656601749 (US); -- HYDROXYCUT ********, 210 Liquid Capsules, UPC 631656600834 (US); -- HYDROXYCUT ********, NEW FORMULA, 210 Liquid Capsules, UPC 631656601756 (US); -- HYDROXYCUT ********, 252 Liquid Capsules, UPC 631656601435 (US); -- HYDROXYCUT ******** (US), POWERFUL NEW FORMULA, 252 Liquid Capsules, UPC 631656601763; -- HYDROXYCUT ******** Shredded Stack Kit 120 count, UPC 631656660623. Recall # F-349-9;
4) HYDROXYCUT MAX - EXTREME-STRENGTH WEIGHT LOSS FOR WOMEN -Dietary Supplement - Distributed under the Iovate and/or MuscleTech brand names in the following sizes and UPC codes: -- HYDROXYCUT Max!, 120 RAPID-RELEASE LIQUID-CAPS (with and without bonus + hydroxy Max Sachet WB), UPC 631656601466 (US); -- HYDROXYCUT Max!, 210 RAPID-RELEASE LIQUID-CAPS (with and without Bonus + 1 Hydroxycut Max Sachet WB), UPC 631656601633 (US). Recall # F-350-9;
5) HYDROXYCUT Max! AQUA SHED - RAPID WATER-SHEDDING FORMULA FOR WOMEN - 60 RAPID RELEASE LIQUID-CAPS - Dietary Supplement - UPC 631656601855 (US) - Distributed under the Iovate and/or MuscleTech brand names.
Recall # F-351-9;
6) HYDROXYCUT CARB CONTROL - Dietary Supplement - Distributed under the Iovate and/or MuscleTech brand names in the following sizes and UPC codes: -- HYDROXYCUT Carb Control 58 count Caps, UPC 631656800036 (US); -- HYDROXYCUT Carb Control 100 count Caps, UPC 631656800029 (US); -- HYDROXYCUT Carb Control 140 count Caps, UPC 631656800012 (US). Recall # F-352-9;
7) HYDROXYCUT 24 - Dietary Supplement - 96 caps/ blister pack, UPC 631656600933 (US) - Distributed under the Iovate and/or MuscleTech brand names. Recall # F-353-9;
8) HYDROXYCUT NATURAL - Dietary Supplement - 100 count, UPC 631656600889 (US) - Distributed under the Iovate and/or MuscleTech brand names. Recall # F-354-9;
9) HYDROXYCUT - Lose Weight Fast - REGULAR DRINK PACKET- Dietary Supplement - Distributed under the Iovate and/or MuscleTech brand names in the following sizes, flavors, and UPC codes: -- HYDROXYCUT Weight Loss Drink Mix, 21 PACKETS, Wild Berry, UPC 631656860191 (US); -- HYDROXYCUT Weight Loss Drink Mix, 21 PACKETS, Country Lemonade, UPC 631656860313 (US); -- HYDROXYCUT Sachet Twin Pack Kit, UPC 631656002362 (US). Recall # F-355-9;
10) Caffeine-Free HYDROXYCUT - Lose Weight Fast - Drink Mix, 21 PACKETS x 3.6g Sachet - Net Weight 76 g - Raspberry Ice, UPC 631656760095 (US) - Distributed under the Iovate and/or MuscleTech brand names. Recall # F-356-9;
11) HYDROXYCUT **** DRINK PACKET - IGNITION STIX - Dietary Supplement - Distributed under the Iovate and/or MuscleTech brand names in the following sizes, flavors, and codes: -- HYDROXYCUT **** IGNITION STIX Drink Mix 2.7 g Sachet, BLUE RASPBERRY, UPC 631656701326 (US); --

HYDROXYCUT **** IGNITION STIX Drink Mix 2.6 g Sachet - FRUIT PUNCH, UPC 631656701319 (US); -- HYDROXYCUT **** IGNITION STIX Drink Mix, 40 STIX (40 pk x 2 g Sachet), Net Wt. 108 g, BLUE RASPBERRY, UPC 631656760125 (US); -- HYDROXYCUT **** IGNITION STIX Drink Mix, 40 STIX (40 pk x 2 g Sachet), Net Wt. 104 g - FRUIT PUNCH, UPC 631656760118 (US). Recall # F-357-9;
12) HYDROXYCUT Max! EXTREME-STRENGTH WEIGHT LOSS FOR WOMEN DRINK PACKETS - Distributed under the following flavors and codes: -- HYDROXYCUT Max! Drink Mix, 40 PACKETS x 2.4g Sachet - Wild Berry, UPC 631656860375 (US); -- HYDROXYCUT Max! Drink Mix, 40 PACKETS x 2.7g Sachet, Net Wt. 108 g - Lemonade, UPC 631656860382 (US). Recall # F-358-9;

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Part II:

13) HYDROXYCUT LIQUID SHOT - Lose Weight Fast - Dietary Supplement - Distributed under the Iovate and/or MuscleTech brand names in the following sizes, flavors, and codes: -- HYDROXYCUT, Lose Weight Fast, Single Shot 2 oz., Wild Berry, UPC 31656800159 (US); -- HYDROXYCUT, Lose Weight Fast, Liquid Shot 2 x 2 oz. Pack, Wild Berry, UPC 631656860207(US); -- HYDROXYCUT, Instant Weight Loss Shot 12 x 2 oz ., Wild Berry, UPC 631656860498 (US); -- HYDROXYCUT Instant Weight Loss Shot 12 x 2 oz., Wild Berry, UPC 631656860498 (US Kit). Recall # F-359-9;
14) HYDROXYCUT **** RTD (READY TO DRINK) - Dietary Supplement -Distributed under the Iovate and/or MuscleTech brand names in the following sizes, flavors, and codes: -- HYDROXYCUT **** RTD, 4 x 8 fl. oz. (946 mL), GRAPE EXPLOSION (GRAPE INFUSION), UPC 631656860436 (US); -- HYDROXYCUT **** RTD, 4 x 8 fl. oz. (946 mL), TRIPLE WILDBERRY, UPC 631656860399 (US); -- HYDROXYCUT **** RTD, 12-Pack, GRAPE INFUSION, UPC 631656860665 (US); -- HYDROXYCUT **** RTD, 12-pack, TRIPLE WILDBERRY, UPC 631656860568 (US); -- HYDROXYCUT **** RTD, 3 x 4-pack, GRAPE INFUSION, UPC 631656860467 (US); -- HYDROXYCUT **** RTD, 3 x 4-pack, TRIPLE WILDBERRY, UPC 631656860443 (US); -- HYDROXYCUT ******** 8 fl. oz., GRAPE EXPLOSION, UPC 631656800265; -- HYDROXYCUT ******** 8 fl. oz. TRIPLE WILDBERRY, UPC 631656800210. Recall # F-360-9
CODE
All lots, sizes, and codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lovate Health Sciences, Inc, Oakville, Canada, by letter and press release on May 1, 2009 and May 7, 2009. Firm initiated recall is ongoing.
REASON
Some Hydroxycut products are associated with a number of serious liver-related illnesses and other health problems. FDA received 23 reports of adverse events associated with use of some Hydroxycut products. As a precaution, the company has decided to recall various Hydroxycut products.
VOLUME OF PRODUCT IN COMMERCE
Approximately 21,067,752 units
DISTRIBUTION
Nationwide and Canada