Minoxidil.com and FDA Drug Recall?

[karlg]

Anyone else get this email?

Urgent Drug Recall

Regrowth, LLC

7049 Greenleaf Avenue

Whittier, CA 90602

www.minoxidil.com

Dear #####

This is to inform you of a product recall involving all of the products prescribed and dispensed to you by Regrowth, LLC.

The recall has been initiated because the U.S. FDA has determined that these products were unapproved by the FDA and may be potential health hazards.

This is a comprehensive list of the Regrowth LLC products:

Product ID Description

002 Retin-A .025% Solution 60 mL bottle

003 Retin-A .05% Solution 60 mL bottle

201 2% Spironolactone Solution 60 mL bottle

205 5% Spironolactone Lotion 2 oz. jar

420 Regrowth Treatment Shampoo (2% Ketoconazole/3% Salicylic Acid) 4oz bottle

500 5% Minoxidil Solution 65 mL bottle

501 5% Minoxidil Solution + Retinoic Acid. 65 mL bottle

540 5% Minoxidil Solution without Propylene Glycol 65 mL bottle

600 5% Xandrox Solution (5% Minoxidil/5% Azelaic Acid) 65 mL bottle

601 5% Xandrox Solution (5% Minoxidil/5% Azelaic Acid) + 0.025% Retinoic Acid 65 mL bottle

640 5% Xandrox Solution (5% Minoxidil/5% Azelaic Acid) without Propylene Glycol 65mL bottle

700 12.5% Minoxidil Solution 125mL bottle

768 6% Minoxidil-PLUS (6% Minoxidil/01% Finasteride) Solution 65mL bottle

925 12.5% Xandrox (12.5% Minoxidil/5% Azelaic Acid) Lotion 125 mL bottle

930 12.5% Xandrox (12.5% Minoxidil/5% Azelaic Acid) Lotion 30 mL bottle

940 Xandrox15 Solution (15% Minoxidil/5% Azelaic Acid) 125 mL bottle

948 Xandrox 15-Plus Solution (15% Minoxidil/5% Azelaic Acid/0.1% Finasteride) 125 mL bottle

The medication or medications you have received contain one or more of the following active ingredients:

Minoxidil [1]

Azelaic Acid [2]

Finasteride[3]

Spironolactone[4]

Retinoic Acid[5]

Ketoconazole[6]

Salicylic Acid[7]

[1] Minoxidil can cause a decrease in the blood pressure, an increase in the heart rate, dizziness on standing (orthostatic hypotension), lightheadedness, headaches and swollen feet/hands.

[2] Azelaic acid can cause hypopigmentation in darkly pigmented patients. It can also make the skin where it is applied more sensitive to sunburn.

[3] Finasteride can cause erectile dysfunction, decreased libido and testicular pain. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Finasteride use may have the potential to cause abnormalities of the external genitalia of a male fetus of a pregnant woman.

[4] Spironolactone applied topically is quickly and completely metabolized. The metabolic products can cause vomiting, diarrhea, stomach pain or cramps, dry mouth, thirst, dizziness, headache, gynecomastia and irregular menses.

[5] Retinoic acid can cause burning and stinging of the skin, lightening of the skin in the treated area, peeling, redness, an unusually warm feeling and unusual dryness.

[6] Ketoconazole in a shampoo can cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, alopecia, rash, urticaria, skin irritation and dry skin.

[7] Salicylic acid can cause mild, temporary burning, itching, irritation, or stinging.

Please complete and return the Customer Response Form shown below as soon as possible. If you have any questions, please ([email protected]).

You are being advised to stop using any and all of these products, and to contact Dr. Lee prior to discarding them.

This recall is being made with the knowledge of the Food and Drug Administration.

Customer Response Form for Regrowth, LLC Recall of All Products

Please check ALL appropriate boxes:

I ##### Customer ID: ##### have read and understand the recall instructions provided in this March 2011 email message ___

I have checked my stock and have quarantined inventory of all Regrowth LLC products ___

Indicate disposition of recalled product(s):

Used (Specify quantity and date) _______

Destroyed (Specify quantity, date and method)

Any adverse events associated with recalled product(s)? Yes ___ No ___

If yes, please explain:



Please complete, copy and send this response form to...................

and this is the message on their homepage:

We're very sorry to inform you that Regrowth LLC has to suspend all operations at this time. In an ongoing audit, the U.S. FDA has deemed our medications to be 'unapproved illegal drugs'. The exorbitant cost of new drug development precludes our pursuing New Drug Applications (NDAs).

Requests for new consultations and orders for medications cannot be processed.

Thank you for your cooperation and understanding.

Richard Lee, M.D.

what's going on? why did they include regular minoxidil on the list of non-FDA drugs?

 

[slurms mackenzie]

No but i did get this one, which is weird

egrowth LLC Patient

Dear Sir Chugalot

You have received an email from Regrowth LLC with the heading of _Urgent Drug Recall_. In fact, there is no urgency at all. The Recall Notifications, which ask if you have used or destroyed the Regrowth LLC product(s), was not sent from or by the FDA. But it was the FDA that mandated Regrowth LLC send the Recall Notifications, using their guidelines for the quarantine and for the disposal of the products(s), thereby making our products appear to be 'dangerous'. This is simply not the case. The products(s) are not in any way contaminated or otherwise defective.

We're very sorry to have caused you all this consternation and confusion and for ourselves for the outcome of the FDA audit, which resulted in the close of Regrowth LLC and the inability to continue servicing your needs.

Richard Lee, M.D.

Consulting Physician

 

[Cassin]

Well that's confusing

 

[slurms mackenzie]

Exactly i'd previously bought topical spironolactone 2% from there, and found out from these boards that the FDA had shut Dr Lee down, and on all the other sites people started reporting getting the similar recall emails.

Yet i'm the only person to date i know of to receive the follow up Email, whether or not it's to do with me being UK based I don't know.

It was sent from a 'Dave Dorius' on the 26th March

 

[The Gardener]

Looks like Dr Lee is out of business.

That really sucks.

 

[Cassin]

Exactly i'd previously bought topical spironolactone 2% from there, and found out from these boards that the FDA had shut Dr Lee down, and on all the other sites people started reporting getting the similar recall emails.

Yet i'm the only person to date i know of to receive the follow up Email, whether or not it's to do with me being UK based I don't know.

It was sent from a 'Dave Dorius' on the 26th March

I got the email from Dave today but not the Dr Lee follow up

 

[The Gardener]

I went to Lee's website and it looks like he's done with.

sh*t... where am I going to get my 12% minoxidil?

Looks like it's shed time for me

 

[Cassin]

I went to Lee's website and it looks like he's done with.

sh*t... where am I going to get my 12% minoxidil?

Looks like it's shed time for me

theres some stuff like it on amazon.

Who knows how good it is but I NEED irritation free 5% so I have no choice but to give them a shot.

 

[The Gardener]

Yes! Found some various makes of minoxidil 15 on Amazon. Thanks for that, Cassin!

I've ordered two brands, the MOPC as someone else suggested on a different thread here, as well as this "Perfect Image" low-PPG minoxidil 15, which seemed to have overwhelmingly the largest number of favorable product reviews:
http://www.amazon.com/gp/product/B003CHYPCW

I'm thinking of trying them both to see which as a better "feel" on my scalp.

Thanks guys for the tips. When I got that email from Dr Lee, I was confused. When I went to his website and saw that he was pretty much closing up shop, I was terrified. I feel better now!

 

[ponder]

Hi there Gardner...how is that "Perfect Image" minoxidil treating you? I just found it on Amazon today and given the reviews (I made sure to read only reviewers that actually have other reviews) are generally pretty positive, was thinking of giving the stuff a whirl.