- 11-10-2013, 02:17 PM
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.
- 11-10-2013, 02:23 PM
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), firstname.lastname@example.org
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 email@example.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.
- 11-10-2013, 04:37 PM
11-10-2013, 04:52 PM
11-10-2013, 05:31 PM
I used it personally when it came out and had no ill effects to speak of. I say its all up to you
Bigger and Better Is all I KNOW!!!
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11-10-2013, 05:37 PM
11-10-2013, 07:52 PM
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.
Serious Nutrition Solutions Representative
X-gels: Arachidonic Acid made affordable
11-10-2013, 10:43 PM
11-10-2013, 11:53 PM
11-11-2013, 12:01 AM
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.
11-11-2013, 12:22 AM
11-11-2013, 12:25 AM
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.
11-11-2013, 12:31 AM
I had a bottle of the og oxy pro and started it up again 2 days ago. Should I stop?
DO IT FOR THE "HOLY, SH*T, YOU GOT HOT"...
11-11-2013, 12:37 AM
11-11-2013, 12:41 AM
11-11-2013, 07:15 AM
11-11-2013, 07:16 AM
11-11-2013, 07:20 AM
My UPC is not on there but I still won't risk it.
DO IT FOR THE "HOLY, SH*T, YOU GOT HOT"...
11-11-2013, 07:27 AM
11-11-2013, 08:00 AM
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
"To your wife you should kiss try today"-Touey
Brotato's bark brings shakes to the pups in the yard
11-11-2013, 08:36 AM
11-11-2013, 12:09 PM
11-11-2013, 02:48 PM
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.
EvoMuse Products Rep
PM me with any questions!
11-11-2013, 02:52 PM
11-11-2013, 03:11 PM
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...
11-11-2013, 03:58 PM
11-13-2013, 01:43 PM
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.
"But as for you, be strong and do not give up, for your work will be rewarded."IRON FLEX SUPPLEMENTS REP SAVE 20% WITH LUKE20 @ IRONFLEXSUPPS.COM
11-13-2013, 02:00 PM
11-13-2013, 02:21 PM
so what's the deal w/ PEW Enhanced then? It has the same ingredient from what I've read.
11-13-2013, 03:24 PM
11-13-2013, 05:29 PM
11-14-2013, 12:37 PM
Is it the Aegeline? If so, did PES license it or are they related as a company?
11-14-2013, 12:52 PM
Interesting that NutraPlanet would send out samples of the capsules and the powder with the OxyElite Protein deal. Both have the UPC numbers listed.
11-15-2013, 07:37 AM
11-15-2013, 08:10 AM
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.
11-15-2013, 08:23 AM
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?
Diet and Nutrition Advisor
11-15-2013, 08:35 AM
11-15-2013, 09:35 AM
11-15-2013, 11:08 AM
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.
11-15-2013, 11:35 AM
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