Bimix/Trimix being RECALLED by government

[nevertooold]

If you are a user of bimix or trimix, be prepared for a recall notice from your compounding pharmacy. The federal government (FDA) and many state pharmaceutical boards are auditing compounders throughout the United States and requiring them to recall product produced between June and September 2013. They are imposing impossible sterile standards that are causing these small businesses owners to shut down their sterile operations.

The bottom line is that almost all pharmacies that have been audited will NOT be able to produce sterile product. That means, no bimix or trimix. I received mine from my long time supplier in northern California. This pharmacy has been around a long time and has never had a single case of non sterile product. They batch test all of their product with independent labs. They are shutting down all of their sterile production because they cannot meet the unfair standards that have been imposed. Ed drugs are about 15% of their business but the federal inspectors required upgrades costing more than $50000.00 .

I was able to find a compounding lab that has not yet been audited, so I can get my bimix refilled. I assume that they soon will have an audit and be in the same situation in the future. My compounding pharmacy said they cannot fight the government so they are shutting down their entire sterile production.

[nevertooold]

I do not see my post on the injections site.

[terraplane]

It's there , wondering where you heard about the recall , sounds like a bad joke to me .

Chuck

[JimStars]

Neverto...

I have not seen any recall notice from my Compounding Pharmacy (in Massachusettts) but they have been NOT making any Trimix since May when the state auditors demanded new Sterile room methods etc.

Hey if anyone demanded my Trimix back it'd have to be pried out of my cold dead hands. One idea tho, is if you do get a recall notice then make up syringes on almost the whole vial and THEN send it back for a full free refill. We know the stuff is sterile so get the most out of the situation.

J

[terraplane]

Ny compounder is the most modern ,sterile lab you will probably see . I doubt they will have any problems . http://www.customedica.com/

Chuck

[dtwarren1942]

I do not see my post on the injections site.

I use an I-pad and quite often do not see my posts. However, if I click on the GO button on the bottom of the page, it refreshes the thread and the more recent "missing" posts come up.

[Peckerwood]

Dear Never,

Would you mind posting the source of your information regarding the recall of Bimix and Trimix? In other words, where did you get the information that you posted.

Thanks,
John

[dtwarren1942]

I found the following regarding a recall for sterility at my pharmacy, Avella. Though not Trimix or Bimix, I sent them an E-mail to inquire if I should be concerned regarding the supply of Trimix.

http://www.fda.gov/Safety/Recalls/ucm367703.htm

I also found this on healing well.com. http://www.healingwell.com/community/de ... &m=2834544

[dtwarren1942]

This is the response I got from my supplier, Avella:
Good Morning

The recall was initiated out of a FDA recommendation from their recent visit to our outside testing facility.   No adverse reactions or issues have been reported from the product. We have since switched to a new testing lab.  

Your product will continue to be compounded and is not part of any recall.

Have a great day.

Respectfully,

Rex Swayne Jr
QA Manager
rex.swayne@avella.com

[limpnoodle]

Guys the issue is with certain "compounding rooms" and sterility. FDA is requiring certain changes to assure sterility of all compounded products. This may mean some major facility and equipment changes for some pharmarcies; so if compounding is a small part of their business then some will not make the investment for the up grades and will stop compounding.