FDA recalls ALRI Venom Hyperdrive 3.0

FitnFirm

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Im sure this info is around here somewhere but I just received an update since I am on the mailing list of the FDA :



FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug
Product poses safety risk

The U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks.

"Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke."

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research Industries Inc. (ALR Industries), Oak View, Calif. On Dec. 24, 2008, ALR Industries initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only "trace amounts" of sibutramine were found in this product, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.

The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact the company at [email protected] to receive further instructions for returning the product and to ask any questions.

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

* Online: MedWatch Online Adverse Event Reporting
* Regular Mail: use postage-paid FDA form 3500 available at: MedWatch - Download reporting forms and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088


FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743. Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2...ty09.htm#Venom
 
LilPsychotic

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Any idea on how much sibutramine was contained per capsule?
 

FitnFirm

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Any idea on how much sibutramine was contained per capsule?

the first notice they ( FDA ) sent out said the list of tainted fat burners had up to 3 times the daily recommended dosage per pill .... so id have to think A LOT !!!!
 
Dwight Schrute

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how you get all those reps?


(stamps back into the cave)
 
rolandajoint

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i think im starting to see a trend with ALRI.....
 
Flyboy

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I have to say all this stuff isn't helping me trust the company....
 
Aggravated

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A list of 20 some fat burners was released a while back. They were listed as tainted. We all saw this coming I suppose.
 
papapumpsd

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This isn't surprising....this is an unregulated, uncontrolled, un-everything industry (dietary supplement). Basically we're all buying from UGs.....think of it that way.

"Buyer Beware".....again, how fitting.
 
Aggravated

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This isn't surprising....this is an unregulated, uncontrolled, un-everything industry (dietary supplement). Basically we're all buying from UGs.....think of it that way.

"Buyer Beware".....again, how fitting.
Yeah true.
 
jjohn

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Yep. Pretty bad sometimes. Yet we're still buying, asking for more. Heck, we're even hanging out in forums to know the latest "supplement" that comes out..
 

FitnFirm

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This isn't surprising....this is an unregulated, uncontrolled, un-everything industry (dietary supplement). Basically we're all buying from UGs.....think of it that way.

"Buyer Beware".....again, how fitting.
I guess some companies that are small are trying to earn every dollar they can in advance of the big changes the FDA is making, which will be another 2 years I think for some such as ALRI.
 
Force of Green

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My review for the original Venom is still on Nulk Butrition. It had some very awkward and severe side effects from it.
 
jjohn

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I felt awesome on this thing. Luckily I just took a sample here and there.
 
Force of Green

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I felt awesome on this thing. Luckily I just took a sample here and there.
I was on it for 5 days at 1 pill with breakfast... it fudged up my appetite and the part of my brain that processes and remembers food likes/dislikes... It took about 5 months for me to get back to normal.
 
TommyTuffGuy

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None of you should even consider buying from ALRI, ever.
 

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Since "suing" was mentioned I figured I'd chime in. Even if you wanted to, you couldn't sue ALRI for violating any of the FDAs labeling prescriptions. The applicable FDA Act does not provide for a private right to sue. In other words, it's a matter that must be entirely resolved by the government. One could however sue ALRI, not for violating FDA provisions, but for injury caused by their product. However, the injury must be actual, not just a possibility. So, unless an individual (or a class of individuals) can show that he was actually harmed by Venom, then there's no standing to sue.
 
EasyEJL

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keep in mind this was only for hyperdrive 3.0, not for 3.0+
 

FitnFirm

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Since "suing" was mentioned I figured I'd chime in. Even if you wanted to, you couldn't sue ALRI for violating any of the FDAs labeling prescriptions. The applicable FDA Act does not provide for a private right to sue. In other words, it's a matter that must be entirely resolved by the government. One could however sue ALRI, not for violating FDA provisions, but for injury caused by their product. However, the injury must be actual, not just a possibility. So, unless an individual (or a class of individuals) can show that he was actually harmed by Venom, then there's no standing to sue.

Ive read about a class action suit, I dont know if its already started or in the works though. Product liability possibly
 
mixedup

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I guess some companies that are small are trying to earn every dollar they can in advance of the big changes the FDA is making, which will be another 2 years I think for some such as ALRI.
i forgot when exactly is the change? this time i need to stock up even heavier than i did when the eph ban came down
 

FitnFirm

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i forgot when exactly is the change? this time i need to stock up even heavier than i did when the eph ban came down



FOR IMMEDIATE RELEASE
June 22, 2007
Media Inquiries:
Michael Herndon
Kimberly Rawlings
301-827-6242
Consumer Inquiries:
888-INFO-FDA



FDA Issues Dietary Supplements Final Rule
The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/...pps062207.html.




http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html
 
b unit

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i checked their website out and they have a letter and they state that "venom hyperdrive may contain undeclared sibutramine"

the fda has found it and alri's own tested results on their website say it contains it. There is no "may" about it, the sibutramine is there, it's been tested and found!

How the hell did it get there in the first place? at those levels it has to have been put there intentionaly, the fact that it just happens to be sibutramine that elevates pulse rate and decreases appetite just makes it more obvious that it was added to boost venom's effectiveness. There was no mistake and I bet they never thought they'd get found out. The F*ckers!!
 

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FitnFirm, a class action lawsuit based on product liability would be a very interesting choice. Product liability is what is known as a strict liability tort claim. Unlike negligence claims, where the focus is on the actions (or inaction) of the defendant, products liability focuses on the product itself. In other words, under strict liability, the manufacturer is liable if the product is defective, even if the manufacturer was not negligent in making that product defective. Because of the potential for such a harsh result, strict liability is applied only to manufacturing defects (when a product varies from its intended design) and almost never applied to design and warning defects. That's the key. The problem here is loosely known as a 'failure to warn' or warning defect, not a manufacturing one. Furthermore, even if this case where held to a strict liability standard and even if a court finds that the manufacturer is strictly liable for its failure to warn, unless there is an actual injury, the case would be dismissed. In other words, strict liability and product liability only come in if the plaintiffs can show an actual injury suffered from the product.
 
EasyEJL

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at those levels it has to have been put there intentionaly
no, thats not true. They get their raws from a supplier, probably from china. Not all manufacturers test every batch of every single ingredient. Imagine how much that would cost muscletech for anabolic halo :D

And if they use contract manufacturing, they may not ever see the raws, and just receive cases of bottles.

so no, it doesnt have to have been put there intentionally. It could be the chinese supplier had an excess of sibutramine due to an order being cancelled, and slipped it in place of sulbutamine or one of the other ingredients.

Also too this was 1 batch found to contain that, and hyperdrive 3.0+ was NOT found to contain that. So if it was on purpose, why did they stop?
 
b unit

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Also too this was 1 batch found to contain that, and hyperdrive 3.0+ was NOT found to contain that. So if it was on purpose, why did they stop?
then why the name change from 3.0 to 3.0+? a bit of a coinicidence that 3.0 contained sulbutamine and 3.0+ didn't.

shouldn't they have named it 3.0- (minus sulbutamine)

seems a huge coinicidence also that other alri products have had unlisted "ingredients" that boost their products effectiveness:think:

just saying
 
EasyEJL

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I'm not saying it wasn't purposefully spiked either :D Just that i'm not so sure, I can see how it could happen without their knowledge. Even with changing the name, if the pharma product worked well, and was inexpensive enough to include, why not keep including it?

And as far as JW, it still seems like it was more a battle over ingredient labeling nomenclature rather than what was actually in it. Part of why they got into trouble with methoxy-trn, making up a compound name isn't exactly according to the DSHEA rules :D
 
b unit

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true

i'd also like to say that i'm sure they (alri) would have taken & actually used the 3.0+ and realsied "hey, these are friggin strong!" maybe we should find out why?

just a thought...
 
EasyEJL

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well, it may have been just 1 batch, again depends on internal policies, they may not test every batch with in house people. Stuff could get shipped directly from a contract manufacturer to a distributor like europa, so in house staff might never see a particular batch. lots of possibilities really.
 

FitnFirm

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i checked their website out and they have a letter and they state that "venom hyperdrive may contain undeclared sibutramine"

the fda has found it and alri's own tested results on their website say it contains it. There is no "may" about it, the sibutramine is there, it's been tested and found!

How the hell did it get there in the first place? at those levels it has to have been put there intentionaly, the fact that it just happens to be sibutramine that elevates pulse rate and decreases appetite just makes it more obvious that it was added to boost venom's effectiveness. There was no mistake and I bet they never thought they'd get found out. The F*ckers!!




considering a prescription dose is anywhere from 5 mg to 20 mg that is quite a lot of drug in one capsule on the test you posted. and on top of that a few MG difference between the two bottles of the same lot # .

I guess when people complained of blood pressure issues it all makes sense now.
 
John Smeton

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you used to rep for them . are you still associated with them Fit n Firm?
 
b unit

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i've sent them an email asking how they expect me to return a bottle of the said product back to them from new zealand? i pay for freight?? what about a refund?? not to mention the other empty bottle i had??

i don't expect to hear back from them :nutkick:
 
LilPsychotic

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you used to rep for them . are you still associated with them Fit n Firm?
I was thinking the same thing when I first saw the thread. They must have done F&F wrong something terrible, I've noticed a few threads attacking them. Rightfully so, after all the controvesy associated with their products. Damn, this is certainly a shady business. I don't know what to think anymore, other than I think its time to find a new hobby...after this crate of supplements is gone.
 

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I was thinking the same thing when I first saw the thread. They must have done F&F wrong something terrible, I've noticed a few threads attacking them. Rightfully so, after all the controvesy associated with their products. Damn, this is certainly a shady business. I don't know what to think anymore, other than I think its time to find a new hobby...after this crate of supplements is gone.

its not an attack by me, the thread is fact that effects human safety. However I am glad not to be affiliated with any company that is not 100% trustworthy, my health is way more important than anything else.
 
Jayhawkk

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Let's keep this in line with information put out and not assumptions and implications of knowlingly commiting a crime, please.
 
John Smeton

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its not an attack by me, the thread is fact that effects human safety. However I am glad not to be affiliated with any company that is not 100% trustworthy, my health is way more important than anything else.
agreed!
 
John Smeton

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Let's keep this in line with information put out and not assumptions and implications of knowlingly commiting a crime, please.
I used venom hyperdrive at work as a stocker back in 2008(Thank God I dont have to do that again and moved on) and was wired all day and got 3 -4x's as much work done as I normally did. The next couple days I was very slow I uncoordinated slow. I got sick (no eating not moving type sick lay in bed dont want to do anything but sleep)after that for one week and wasnt well and healthy again for 3-6 weeks after.

could it have been the hyperdrive I think so..could it have been something else ..possibly..anyways its over. and Im well..I didnt go to the doctor if I remember...Ill never use there products again though. I mean the hyperdrive seemed to electrify my mind.
 
LilPsychotic

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Thats a text book case of adverse effects brought on by stimulant use.
 
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then why the name change from 3.0 to 3.0+? a bit of a coinicidence that 3.0 contained sulbutamine and 3.0+ didn't.

shouldn't they have named it 3.0- (minus sulbutamine)

seems a huge coinicidence also that other alri products have had unlisted "ingredients" that boost their products effectiveness:think:

just saying
houldn't they have named it 3.0- (minus sulbutamine).........hahaha classic
 
papapumpsd

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houldn't they have named it 3.0- (minus sulbutamine).........hahaha classic
Let's stop confusing the chemical here...it's "sibutramine", NOT "sulbutamine".

Google them....
 
Jayhawkk

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Didn't notice the spelling difference... Both are compounds?
 
EasyEJL

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yeah, was my fault, I used sulbutamine in a sentence :) its in a number of fat burners.
 
papapumpsd

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Didn't notice the spelling difference... Both are compounds?
Ya Jay, both are compounds. Sibutramine, I believe, is meridia....a Rx for weight control. It came out years ago and there were reports of diarrhea with its use. Not sure of other sides.

BTW, I'm using sulbutiamine from NP. There's Sibutramine and sulbutamine as well. No wonder there are mistakes in chemical reference!!! :tongue-tied:
 
EasyEJL

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Ya Jay, both are compounds. Sibutramine, I believe, is meridia....a Rx for weight control. It came out years ago and there were reports of diarrhea with its use. Not sure of other sides.

BTW, I'm using sulbutiamine from NP. There's Sibutramine and sulbutamine as well. No wonder there are mistakes in chemical reference!!! :tongue-tied:
and then imagine trying to order one of these over the phone from a lab in china :D
 
papapumpsd

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and then imagine trying to order one of these over the phone from a lab in china :D
I really wouldn't have the patients to do that. I can hardly handle ordering Chinese take-out over the phone. I get incredibly pissed off.
 
Aeternitatis

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I used venom hyperdrive at work as a stocker back in 2008(Thank God I dont have to do that again and moved on) and was wired all day and got 3 -4x's as much work done as I normally did. The next couple days I was very slow I uncoordinated slow. I got sick (no eating not moving type sick lay in bed dont want to do anything but sleep)after that for one week and wasnt well and healthy again for 3-6 weeks after.
Exactly my experience. I got a bunch of the sample packs for free.
 
b unit

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yeah, was my fault, I used sulbutamine in a sentence :) its in a number of fat burners.
yeah, i copy and pasted that from that post, my apologies also for using the incorrect name/spelling
 

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