Re: Fw: Enforcement Report for July 22, 2009

[Guest guest]

Wow, thanks for posting that BJ.

I see that a number of the recalls were all for certain manufacturing

companies (i.e. all the drugs on one list were for the company,

Advantage LLC and so on.) That means obviously we'd want to avoid any

prescriptions created at those companies.

I get my T3/T4 pills made for me at a compounding pharmacy. Hopefully

this means they source their ingredients locally, but I will make sure

and ask. It may be more of a hassle to pay extra for compounded drugs,

but now I'm starting to think it's worth the quality points...!

-Serena

>

>

> There are several recalls for thyroid meds including Armour, $ynthroid,

> Levothroid, Cytomel and the Mylan (T4) generics. Click on the link for the

> enforcement report and scroll through to RECALLS AND FIELD CORRECTIONS:

> DRUGS - CLASS II

>

> It states these drugs are NOT in conformance with Non-Compliance with

> current Good Manufacturing Practices (GMPs).

>

> I think that is a serious offense!

>

> Glad I was switched to NatureThyroid

> ~Bj

>

>

>

>

> Subject: Enforcement Report for July 22, 2009

> Date: Wednesday, July 22, 2009, 4:54 PM

>

> Enforcement Report for July 22, 2009

> Wed, 22 Jul 2009 13:20:00 -0500

> The FDA Enforcement Report is published weekly by the Food and Drug

> Administration, Department of Health and Human Services. It contains

> information on actions taken in connection with agency Regulatory

> activities.

>

> ----------------------------------------------------------

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> GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA)

> · 5600 Fishers Lane · Rockville MD 20857 ·

>

>

> Just in case the link didn't go through...

> http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm173256.htm

>

>

--

" Basically, civilization

needs a new operating system, you are the programmers, and we need it within

a few decades. "

- Hawken

[Guest guest]

i used to be a pharmacy tech but i have no idea what those Charges mean

someone wrote on another forum that this didn't mean the Potency of those meds

was bad.. but That makes me wonder even more what the Non-conformance means RE:

the Quality and efficacy of those meds..

~*btw, i have read from a few different sources now that (RLC?brainfog) labs who

makes Naturethroid and WEstthroid have never had a " charge " against their meds

in their 85+ year history i believe that is one of the reasons that dr Lowe

likes them so much

-Carol

>

>

> From: U.S. Food & Drug Administration (FDA) <fda@>

> Subject: Enforcement Report for July 22, 2009

> Date: Wednesday, July 22, 2009, 4:54 PM

>

>

> Enforcement Report for July 22, 2009

> Wed, 22 Jul 2009 13:20:00 -0500

> The FDA Enforcement Report is published weekly by the Food and Drug

Administration, Department of Health and Human Services. It contains information

on actions taken in connection with agency Regulatory activities.

>

>

--------------------------------------------------------------------------------

>

> Manage your FDA Subscriptions:

> •Update your preferences or unsubscribe

> •Questions about this service? support@

> •Other inquiries? webmail@

> GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) ·

5600 Fishers Lane · Rockville MD 20857 ·

>

>

> Just in case the link didn't go through...

> http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm173256.htm

>

[Guest guest]

Here is the FDA definitions

Background and Definitions

Recalls are actions taken by a firm to remove a product from the market. Recalls

may be conducted on a firm's own initiative, by FDA request, or by FDA order

under statutory authority.

Class I recall: a situation in which there is a reasonable probability that the

use of or exposure to a violative product will cause serious adverse health

consequences or death.

Class II recall: a situation in which use of or exposure to a violative product

may cause temporary or medically reversible adverse health consequences or where

the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product

is not likely to cause adverse health consequences.

Market withdrawal: occurs when a product has a minor violation that would not be

subject to FDA legal action. The firm removes the product from the market or

corrects the violation. For example, a product removed from the market due to

tampering, without evidence of manufacturing or distribution problems, would be

a market withdrawal.

Medical device safety alert: issued in situations where a medical device may

present an unreasonable risk of substantial harm. In some case, these situations

also are considered recalls.

----

NDC means National Drug Code and there's a directory on the FDA site.

I don't know the history of RLC Labs, but I do know that Unithroid is the only

T4 or Levothyroxine Sodium product to never have a recall and it was the first

to be FDA approved. It's manufactured by Jerome s Pharmaceuticals and

marketed by Lannett Pharmaceuticals.

I'll have to do a little research.

~Bj

> >

> >

> > From: U.S. Food & Drug Administration (FDA) <fda@>

> > Subject: Enforcement Report for July 22, 2009

> > Date: Wednesday, July 22, 2009, 4:54 PM

> >

> >

> > Enforcement Report for July 22, 2009

> > Wed, 22 Jul 2009 13:20:00 -0500

> > The FDA Enforcement Report is published weekly by the Food and Drug

Administration, Department of Health and Human Services. It contains information

on actions taken in connection with agency Regulatory activities.

> >

> >

--------------------------------------------------------------------------------

> >

> > Manage your FDA Subscriptions:

> > •Update your preferences or unsubscribe

> > •Questions about this service? support@

> > •Other inquiries? webmail@

> > GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA)

· 5600 Fishers Lane · Rockville MD 20857 ·

> >

> >

> > Just in case the link didn't go through...

> > http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm173256.htm

> >

>