Here is the email I received:
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 contact Dave Dorius (ReplyToRecall@minoxidil.com).
You are being advised to stop using any and all of these products and to destroy them.
This recall is being made with the knowledge of the Food and Drug Administration.
---------------
Anyone knows anything about this?
Minoxidil.com says:
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.
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 contact Dave Dorius (ReplyToRecall@minoxidil.com).
You are being advised to stop using any and all of these products and to destroy them.
This recall is being made with the knowledge of the Food and Drug Administration.
---------------
Anyone knows anything about this?
Minoxidil.com says:
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.
