Palo Alto Labs
Dave
Aspire36 Voluntary Recall
In cooperation with the FDA, Palo Alto Labs is issuing a voluntary recall for Aspire36.
As I have posted in other threads, we have countless tests showing that Aspire36 is clear of all active prescription PDE-5 inhibitors; we’ve also tested for all known analogs of prescription PDE-5 inhibitors. All of our tests repeatedly came back negative.
According to the FDA, Aspire36 contains trace amounts of Aildenafil and Dimethyl sildenafil thione (sulfoaildenafil). I will post our initial lab analysis from 4/19/2007, months before Aspire36 even went on the market, which shows NEGATIVE for Dimethylsidenafil.
While Dimethyl sildenafil thoine is an analog of sildenafil, it is our understanding that this compound was not discovered as a sildenafil analog until around September or October. This would indicate why our initial and subsequent lab analysis came back negative. We have contacted the 3 labs that we regularly use for testing, none of which were aware of this analog, and therefore did not test in accordance.
We have limited knowledge and/or information in regards to Aildenafil, as it is not an analog of sildenafil, and not a compound that had been recommended to test for, as it remains unknown.
We test EVERY batch of Aspire36 for actives and known analogs, since these have always returned negative, we have recently (2/20/08) submitted Aspire36 to yet another lab for further testing. We have yet to receive the results of this analysis, but we will post the results once they are available to us.
We are currently actively working with the FDA to ensure this action will be handled appropriately.
This notice will be publicly available on the FDA’s website within the next few days. I felt that it was in PAL’s best interest to publicly announce this to our loyal forum supporters, rather than waiting for someone to discover the FDA notice.
Thank you
Dave
In cooperation with the FDA, Palo Alto Labs is issuing a voluntary recall for Aspire36.
As I have posted in other threads, we have countless tests showing that Aspire36 is clear of all active prescription PDE-5 inhibitors; we’ve also tested for all known analogs of prescription PDE-5 inhibitors. All of our tests repeatedly came back negative.
According to the FDA, Aspire36 contains trace amounts of Aildenafil and Dimethyl sildenafil thione (sulfoaildenafil). I will post our initial lab analysis from 4/19/2007, months before Aspire36 even went on the market, which shows NEGATIVE for Dimethylsidenafil.
While Dimethyl sildenafil thoine is an analog of sildenafil, it is our understanding that this compound was not discovered as a sildenafil analog until around September or October. This would indicate why our initial and subsequent lab analysis came back negative. We have contacted the 3 labs that we regularly use for testing, none of which were aware of this analog, and therefore did not test in accordance.
We have limited knowledge and/or information in regards to Aildenafil, as it is not an analog of sildenafil, and not a compound that had been recommended to test for, as it remains unknown.
We test EVERY batch of Aspire36 for actives and known analogs, since these have always returned negative, we have recently (2/20/08) submitted Aspire36 to yet another lab for further testing. We have yet to receive the results of this analysis, but we will post the results once they are available to us.
We are currently actively working with the FDA to ensure this action will be handled appropriately.
This notice will be publicly available on the FDA’s website within the next few days. I felt that it was in PAL’s best interest to publicly announce this to our loyal forum supporters, rather than waiting for someone to discover the FDA notice.
Thank you
Dave
