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    oep recall


    Just curious everyones thoughts on the recall of oep. I have a 180 ct of the advanced formula waiting in the wings to cut in the new year. the problems all seem to be in hawaii, and i believe some in arizona, and im all the way in md. i know theres been some threads about this before but why would all the problems be so centralized if all the oep is made in the same place (if it is i am not sure of that, just speculating).

    ive run all forms of oep except the advanced formula many times with no problems. im trying to decide if i wanna go throught the trouble of sending it back or just saying f it and running it anyway. wondering what some of you guys smarter than me about this stuff would do or are going to do if you have som oep.

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    HomeNews & EventsNewsroomPress Announcements
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    FDA NEWS RELEASE
    For Immediate Release: Nov. 10, 2013
    Media Inquiries: Theresa Eisenman, 301-796-2805 (office) or 240-328-3137 (cell), theresa.eisenman@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA


    USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
    The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.

    The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.

    “We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”

    The products involved in the recall include:

    OxyElite Pro Super Thermo capsules
    --two count capsules UPC #094922417275
    --10 count capsules UPC #094922417251
    --10 count capsules UPC #094922417268
    --21 count capsules UPC #094922426604
    --90 count capsules UPC #094922395573
    --90 count capsules “Pink label” UPC #094922447906
    --180 count capsules UPC #094922447852

    OxyElite Pro Ultra-Intense Thermo capsules
    --three count capsules UPC #094922447883
    --three count capsules UPC #094922447876
    --90 count capsules UPC #094922395627
    --180 count capsules UPC #094922447869

    OxyElite Pro Super Thermo Powder
    --Fruit Punch 0.15 oz UPC #094922417237
    --Fruit Punch 0.15 oz UPC #094922447517
    --Fruit Punch 4.6 oz UPC #094922426369
    --Fruit Punch 5 oz. UPC #094922447487
    --Blue Raspberry 4.6 oz UPC #094922426376
    --Grape Bubblegum 4.6 oz UPC #094922447500
    --Green Apple 4.6 oz. UPC #094922426499

    By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

    In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

    In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

    In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

    Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

    If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

    Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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    Quote Originally Posted by kenny76 View Post
    HomeNews & EventsNewsroomPress Announcements
    -
    FDA NEWS RELEASE
    For Immediate Release: Nov. 10, 2013
    Media Inquiries: Theresa Eisenman, 301-796-2805 (office) or 240-328-3137 (cell), theresa.eisenman@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA

    USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
    The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.

    The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.

    "We took this step to ensure that adulterated and harmful products do not reach the American public," said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. "We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public."

    The products involved in the recall include:

    OxyElite Pro Super Thermo capsules
    --two count capsules UPC #094922417275
    --10 count capsules UPC #094922417251
    --10 count capsules UPC #094922417268
    --21 count capsules UPC #094922426604
    --90 count capsules UPC #094922395573
    --90 count capsules "Pink label" UPC #094922447906
    --180 count capsules UPC #094922447852

    OxyElite Pro Ultra-Intense Thermo capsules
    --three count capsules UPC #094922447883
    --three count capsules UPC #094922447876
    --90 count capsules UPC #094922395627
    --180 count capsules UPC #094922447869

    OxyElite Pro Super Thermo Powder
    --Fruit Punch 0.15 oz UPC #094922417237
    --Fruit Punch 0.15 oz UPC #094922447517
    --Fruit Punch 4.6 oz UPC #094922426369
    --Fruit Punch 5 oz. UPC #094922447487
    --Blue Raspberry 4.6 oz UPC #094922426376
    --Grape Bubblegum 4.6 oz UPC #094922447500
    --Green Apple 4.6 oz. UPC #094922426499

    By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

    In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

    In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

    In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

    Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

    If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA's MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

    Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
    Do you seem them banning alcohol? Just a means to make the industry look bad and shady.
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    Quote Originally Posted by fightbackhxc View Post

    Do you seem them banning alcohol? Just a means to make the industry look bad and shady.
    Lol alcohol and cigarettes have killed a countless number of people but no ones complaining about those drugs right? Typical...
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    I used it personally when it came out and had no ill effects to speak of. I say its all up to you
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    Quote Originally Posted by fightbackhxc View Post

    Do you seem them banning alcohol? Just a means to make the industry look bad and shady.
    I figured the same, really i was just curious what everyone else was thinking. I actually took a purple cap oep right after i posted.
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    I would send them back tbh. Why risk it? The cases arn't as localised as you think. Hawaii is a small place so finding a cause (or correlation) is much easier than somewhere like the U.S where everything is spread out.

    A case of liver failure (media reported at least) was identified as far away as New Zealand and the person had also used the new OEP powder. Be very wary.

    Or at least hold on to them until they find out what is causing this issue.
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    Quote Originally Posted by fightbackhxc View Post
    Do you seem them banning alcohol? Just a means to make the industry look bad and shady.
    .At least you know you're gonna have liver problems with excess alcohol. Tobacco sides are insane. Unknowingly having liver failure blows though. Even if an isolated incident.
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    Quote Originally Posted by fightbackhxc View Post
    Do you seem them banning alcohol? Just a means to make the industry look bad and shady.
    Probably one of the dumbest statements I've ever heard.
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    Quote Originally Posted by JD261985 View Post
    Lol alcohol and cigarettes have killed a countless number of people but no ones complaining about those drugs right? Typical...
    Ok your not very bright either. Yes alcohol can be dangerous when misused but guess what moderate alcohol consumption is healthier than complete abstinence. So lets say the recommended dosage of alcohol is 1-2 drinks a day. I go ahead and have 1-2 drinks a day for a month everyday. Do you think my liver is going to fail or anyone for that matter? No, hell no. Sorry there seems to be a link between OEP and liver failure which seems to develop pretty rapidly. Alcohol consumption would have to be excessive and for years to cause liver failure. Leave alcohol out of this your just grasping at straws.

    Cigarettes another brilliant argument that has nothing to do with the supplement industry. I don't smoke I'm aware they are bad but there is a clear warning one what they can do to ones health over the long term. I don't see a warning on OEP that says may cause liver failure. Admittedly I know nothing about these finding but using cigs and alcohol to prove a point is stupid, they have clear warning signs and age restrictions. I love my supplements and don't want this to start a **** storm either but lets stay on topic.
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    Quote Originally Posted by JD261985 View Post
    Lol alcohol and cigarettes have killed a countless number of people but no ones complaining about those drugs right? Typical...

    Yeah and rape and murder are bad also, what's your point?. Alcohol and cigarettes are a ridiculous argument or comparison to supplements.
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    Anyway, I didn't see the "Advanced" version listed on the recall. Also as far as I know, Usp Labs didn't make a 180 count bottle of the Advanced formula.
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    I had a bottle of the og oxy pro and started it up again 2 days ago. Should I stop?
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    Quote Originally Posted by puccah8808 View Post
    I had a bottle of the og oxy pro and started it up again 2 days ago. Should I stop?
    I would. Personally I would not risk liver failure for $60 in supps. Grab some Alphamine and call it an upgrade I think it was the newer formulas but not 100% I wouldn't risk it either way
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    Quote Originally Posted by Afi140 View Post
    I would. Personally I would not risk liver failure for $60 in supps. Grab some Alphamine and call it an upgrade I think it was the newer formulas but not 100% I wouldn't risk it either way
    I've been using alphamine, which I love. I guess oxy was my last resort or a step before I try eca. Thanks!
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    Quote Originally Posted by T-Bone View Post
    Anyway, I didn't see the "Advanced" version listed on the recall. Also as far as I know, Usp Labs didn't make a 180 count bottle of the Advanced formula.
    Its on there, my exact upc # is in the recall.
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    Quote Originally Posted by kenny76 View Post

    Its on there, my exact upc # is in the recall.
    Its under "ultra intense thermo"
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    My UPC is not on there but I still won't risk it.
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    Quote Originally Posted by puccah8808 View Post
    My UPC is not on there but I still won't risk it.
    It appears to only be the versions containing aegeline which i dont see listed fot the og, but they are still saying avoid oep and versa 1 altogether.
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    Trying to understand these are tampered fake bottles to look like USP or sent out from USPlab in a bad condition because they no controlling quality at this company
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    Quote Originally Posted by Afi140 View Post
    I would. Personally I would not risk liver failure for $60 in supps. Grab some Alphamine and call it an upgrade I think it was the newer formulas but not 100% I wouldn't risk it either way
    It is the newer formula. The og OEP was used by many many people for a long time with no issues. No need to stretch this further than it has to be. They aren't recalling the og OEP.
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    Quote Originally Posted by drewsicle3210 View Post
    It is the newer formula. The og OEP was used by many many people for a long time with no issues. No need to stretch this further than it has to be. They aren't recalling the og OEP.
    I don't think they could recall OG OEP after being forced to destroy all available OG OEP they had by the FDA :P
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    OEP powder and Versa 1 bottle (ran Versa 1 already, didn't really respond). Sucks to see this, but hardly surprising considering all the reports.
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    Quote Originally Posted by kissdadookie View Post
    I don't think they could recall OG OEP after being forced to destroy all available OG OEP they had by the FDA :P
    They actually could recall it, if they needed to. Just because they destroyed what they had on hand, doesn't mean that consumers destroyed theirs as well. There are so many bottles of og OEP sitting in people's supp stashes, mine included. It is a good supplement.
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    Quote Originally Posted by drewsicle3210 View Post
    They actually could recall it, if they needed to. Just because they destroyed what they had on hand, doesn't mean that consumers destroyed theirs as well. There are so many bottles of og OEP sitting in people's supp stashes, mine included. It is a good supplement.
    That's not a recall though, that's just stock floating around flying under the FDA's radar :P

    I thought that the FDA made it clear that DMAA products can no longer be sold and they've already forced the two biggest distributors of OG Jack3d and OEP to destroy all available stock of the products. Wouldn't an actual recall only apply to things that are still currently legally in circulation and being sold? If you're still selling the product doesn't that fall more in line with breaking FDA regulations? Just throwing it out there :P

    Or does recall mean something else entirely which I am not aware of? Could very possibly be the case...
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    Quote Originally Posted by kissdadookie View Post
    That's not a recall though, that's just stock floating around flying under the FDA's radar :P

    I thought that the FDA made it clear that DMAA products can no longer be sold and they've already forced the two biggest distributors of OG Jack3d and OEP to destroy all available stock of the products. Wouldn't an actual recall only apply to things that are still currently legally in circulation and being sold? If you're still selling the product doesn't that fall more in line with breaking FDA regulations? Just throwing it out there :P

    Or does recall mean something else entirely which I am not aware of? Could very possibly be the case...
    correct ~The FDA classified it as an unapproved drug and illegal to sale in the US, therefore there is not reason to do a recall

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    Am I the only one that had the initial thought that this was the FDA's way of messing with USP? I mean after USP fought them on the DMAA and ultimately were proven right in a very hush hush statement of the studies. PA was rather pissed about that.
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    Quote Originally Posted by lukehayd View Post
    Am I the only one that had the initial thought that this was the FDA's way of messing with USP? I mean after USP fought them on the DMAA and ultimately were proven right in a very hush hush statement of the studies. PA was rather pissed about that.
    It certainly got them on the radar more I'm sure. But any supplement company with the link (not saying it's true) like this to liver failure would be in the same boat.
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    so what's the deal w/ PEW Enhanced then? It has the same ingredient from what I've read.
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    Quote Originally Posted by redbirdfan1 View Post
    so what's the deal w/ PEW Enhanced then? It has the same ingredient from what I've read.
    I guess we'll see what comes of it. I haven't heard anything about PES or Enhanced in the news.
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    Quote Originally Posted by redbirdfan1 View Post
    so what's the deal w/ PEW Enhanced then? It has the same ingredient from what I've read.

    The more people bring it up, the more likely the FDA will catch on..
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    Is it the Aegeline? If so, did PES license it or are they related as a company?
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    Interesting that NutraPlanet would send out samples of the capsules and the powder with the OxyElite Protein deal. Both have the UPC numbers listed.
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    Bump
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    Quote Originally Posted by kenny76 View Post
    Just curious everyones thoughts on the recall of oep. I have a 180 ct of the advanced formula waiting in the wings to cut in the new year. the problems all seem to be in hawaii, and i believe some in arizona, and im all the way in md. i know theres been some threads about this before but why would all the problems be so centralized if all the oep is made in the same place (if it is i am not sure of that, just speculating).

    ive run all forms of oep except the advanced formula many times with no problems. im trying to decide if i wanna go throught the trouble of sending it back or just saying f it and running it anyway. wondering what some of you guys smarter than me about this stuff would do or are going to do if you have som oep.
    First off I want to say ai have no connection with USP.

    There is no logical way that such a small percentage of the population would get sick. The way a distributor works is that they buy a huge amount of product and then "distribute" it everywhere. So it would not be possible to separate the cases by state to state. Then calculate the percentage of people getting it in Hawaii and factor in the amount of people who would then have liver failure and you are looking at a large outbreak of cases. This is all propaganda by the FDA to control our supplements. It has nothing to do with USP or OXY, the only things that would make sense are counterfeit OXY (small batches made in Hawaii bc of shipping costs of the products) or people just plain overdosing for very long periods of time (user error).

    Just had to say something bc the Medias stupidity is mind numbing.
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    http://www.hawaiinewsnow.com/story/2...e-getting-sick
    The woman in the video say's she bought suspect looking OEP product off the internet. Also mentions the woman that died was refused a liver transplant as she already had cancer.

    This was linked on another site ^^^

    This is interesting!
    Could it be that Hawaii had a corrupt copy being sold? - Possible!
    Some of the people by the looks of it who became ill/died could have had other complicating issues before taking the product/s? - Possible as suggested!
    Labelling does state if you have known complications/illnesses then avoid the use! People still chose to use? Corrrect!
    Some where also taking other products at the time of the issues? Correct! But nothing said against these other products and not even named, why?

    If Aegeline is to blame then why havent the FDA contacted ALL companies using said ingredient? Confused! FDA are supposed to be the governing body for safety in this industry! If so then they should be making other companies recall any products with this ingredient in for consumer safety reasons but it would only seem that USPlabs have been targeted, Why?
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    Quote Originally Posted by redbirdfan1 View Post
    so what's the deal w/ PEW Enhanced then? It has the same ingredient from what I've read.
    It's been discontinued according to the site.
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    Quote Originally Posted by jbryand101b View Post

    It's been discontinued according to the site.
    Oh wow it has. Huh.
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    Please be careful, should you decide to use OEP powder. I started in June 2013 and had KILLER results. But then I started feeling lousy, with tremendous fatigue and nausea. Then the jaundice set in as well as other unpleasant side effects I won't gross you out with. I ended up in the ER on September 11. My LFTs were off the charts (worse than any cirrhosis of the liver would cause and in only a VERY short period of time). They were considering wheeling me in for emergency gall bladder removal, but after CT scan, MRI and ultrasound, they found no masses, tumors, blockages, and I had no abdominal pain. With process of elimination and many, many tests by several doctors, it was determined the OEP powder was the culprit. The ONLY thing that saved my liver was my daily habit of drinking a gallon of water and a clean diet sans alcohol. After 12 weeks, my liver functions are all normal with the exception of direct bilirubin. Note that I took less than the recommended dosage because of the nausea. As far as demographics, I live in Connecticut. I bought one tub at GNC and the other through the supplement shop at a local gym, but never used the latter.

    Not here to preach - only to tell you to PLEASE be careful. You do NOT want to go through daily blood draws (some days were 6+ vials), out of pocket expense and just not knowing if there is permanent damage.
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    Quote Originally Posted by Jenyfur View Post
    Please be careful, should you decide to use OEP powder. I started in June 2013 and had KILLER results. But then I started feeling lousy, with tremendous fatigue and nausea. Then the jaundice set in as well as other unpleasant side effects I won't gross you out with. I ended up in the ER on September 11. My LFTs were off the charts (worse than any cirrhosis of the liver would cause and in only a VERY short period of time). They were considering wheeling me in for emergency gall bladder removal, but after CT scan, MRI and ultrasound, they found no masses, tumors, blockages, and I had no abdominal pain. With process of elimination and many, many tests by several doctors, it was determined the OEP powder was the culprit. The ONLY thing that saved my liver was my daily habit of drinking a gallon of water and a clean diet sans alcohol. After 12 weeks, my liver functions are all normal with the exception of direct bilirubin. Note that I took less than the recommended dosage because of the nausea. As far as demographics, I live in Connecticut. I bought one tub at GNC and the other through the supplement shop at a local gym, but never used the latter. Not here to preach - only to tell you to PLEASE be careful. You do NOT want to go through daily blood draws (some days were 6+ vials), out of pocket expense and just not knowing if there is permanent damage.
    Wow
  

  
 

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