FDA Recalls All Regrowth LLC Products (Maker of Xandrox)

Note: This post comes from one of our favorite readers (he has requested to remain anonymous), who has also contributed posts in the past about FDA issues:

The FDA’s oversight of drugs that have not been evaluated for safety and efficacy in their prescribed formulations and are thought to pose (potential) hazards has been summarized in previous blogs. On May 25, 2011, the FDA recalled drugs from a manufacturer (Regrowth, LLC) selling products online. This action was taken due to their status as “unapproved drugs (that) may present potential health hazards” (see

FDA.gov

).

While the recall is for the manufacturer and not users of the drug(s), and it appears that no serious adverse effects have been listed, users should also be aware of the FDA’s action and the caution that other unproven products are sold online with unstudied risk/benefit profiles. The failure to recall these other products and stop their sale is less likely an acceptance of their appropriateness and more likely a reflection of the FDA as a underresourced regulatory agency that has to devote their time to many priorities. Although any given person may benefit from such products, the actual degree of benefit and short-and long-term risks, is unknown (i.e. ‘Buyer Beware’). It is also noteworthy that the drugs sold by Regrowth, LLC -as with many online ventures -were being distributed on a massive scale (to individuals in over 70 countries or regions).

Below is taken from the FDA website and verbatim language of this public notification:

PRODUCT

1. Retinoic Acid 0.025% (containing 0.025% Retin-A) Topical solution, 60 mL bottle, Recall # D-513-2011;
2. Retinoic Acid 0.05% (Containing 0.05% Retin-A) Topical solution, 60 mL bottle, Recall # D-514-2011;
3. 2% Spironolactone Topical Solution, 60 mL bottle, Rx. Recall # D-515-2011;
4. 5% Spironolactone Lotion, 2 oz jar, Rx. Recall # D-516-2011;
5. Treatment Shampoo (2% Ketoconazole and 3% Salicylic Acid) Topical Solution, 4 oz bottle, Rx. D-517-2011;
6. Minoxidil 5% Topical Solution, 65 ml bottle, Rx. Recall # D-518-2011;
7. Minoxidil 5% with 0.025% Retinoic Acid Topical Solution, 65 mL bottle, Rx. Recall # D-519-2011;
8. Minoxidil 5% Topical Solution without Propylene Glycol, 65 mL bottle, Rx. Recall # D-520-2011;
9. Xandrox (5% Topical Minoxidil Azelaic Acid Solution), Day Time Formulation, 65 ml bottle, Rx. Recall # D-521-2011;
10. Xandrox with .025 Retinoic Acid (5% Topical Minoxidil Azelaic Acid) Solution, Nigh Time formulation, 65 ml bottle, Rx. Recall # D-522-2011;
11. Xandrox without Propylene Glycol (5% Minoxidil Azelaic Acid) Solution, 65 ml bottle, Rx. Recall # D-523-2011;
12. 12.5% Minoxidil Solution, 125 mL bottle, Rx. Recall # D-524-2011;
13. 6% Minoxidil Plus Solution, 65 ml bottle, Rx. Recall D-525-2011;
14. Xandrox Medicated Lotion (12.5% Minoxidil and 5% Azelaic Acid), 30 mL and 125 mL bottle, Rx. Recall # D-526-2011;
15. Xandrox 15 (15% Minoxidil and 5% Azelaic Acid) Solution, 125 mL bottle. Recall # D-527-2011;
16. Xandrox 15-Plus (15% Minoxidil, 5% Azelaic Acid and 0.1% Finasteride) Solution, 125 mL bottle. Recall # D-528-2011

CODE
All lots

RECALLING FIRM/MANUFACTURER
Regrowth, LLC, Whittier, CA, by letters on March 29, 2011. FDA initiated recall is ongoing.

REASON
Marketed Without an Approved NDA/ANDA: These products are unapproved drugs and may present potential health hazards.

VOLUME OF PRODUCT IN COMMERCE
57,999 bottles

DISTRIBUTION
Nationwide, Argentina France Malta South Africa Australia Germany Mauritius South Korea Austria Greece Mexico Spain Azerbaijan Guam Netherlands Sweden Bahrain Hong Kong New Zealand Switzerland Belgium Hungary Northern Ireland Taiwan Bolivia Iceland Norway Thailand Brazil Indonesia Peru Trinidad Bulgaria Ireland Philippines Turkey Canada Israel Poland UAE China Italy Portugal Ukraine Colombia Japan Puerto Rico United Kingdom Croatia Jordan Qatar Uruguay Cyprus Kuwait Republic of Georgia Vietnam Czech Republic Latvia Romania Yugoslavia Denmark Lebanon Russia Ecuador Lithuania Scotland Estonia Macau Serbia Faroe Islands Malaysia Singapore Finland Maldives Slovenia