What happened
Original notice title
AnuMed International, LLC MARCS-CMS 674310, August 20, 2024
From the archived source record
As described below, your above-mentioned products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B). Continue as needed if cravings arise and to help avoid weight regain.” Magnesium 50 mg Body Cream On the product webpage: • “Highly Effective for Leg Cramps, Muscle Soreness, Nighttime Leg Discomfort, Inflammation Relief” • “Magnesium is important for many processes in the body. Lower the risk of urinary tract infections (UTIs) . . . Lower the risk of urinary tract infections (UTIs) . . . As a result, the B-12 . . . solution may help support and replace the lack of the nutrient while improving cognitive function.” • “When the body has a deficiency of the vitamin, harmful bacteria begins to grow. Misbranded Drugs “Magnesium 50 mg Body Cream,” “AnuMed™ 25mg Per Pump PROGESTERONE CREAM,” “AnuMed™ 2.5 All Natural ESTRIOL CREAM,” “AnuMed™ 5.0 All Natural ESTRIOL CREAM,” “AnuMed™ BIO-IDENTICAL BIO-EST 2.5mg PER PUMP,” “AnuMed™ BIO-IDENTICAL BIO-EST 5mg Per Pump,” “AnuMed™ Bio-Identical DHEA 50 CREAM” and “AnuMed™ Bio-Identical DHEA 20 CREAM” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labels and/or websites include statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. The above assertions misleadingly suggest that the above-mentioned drug products are approved or endorsed by FDA in some way.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 5e33ff6a7527
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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