What happened
Original notice title
Clarke Pharmaceutical Manufacturing, Inc. MARCS-CMS 610642, February 02, 2021
From the archived source record
Food and Drug Administration (FDA) reviewed your website at the Internet address www.clarkepharmaceuticals.com in December 2020 and January 2021, and has determined that you take orders there for the products “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream.” We have also reviewed your YouTube video recordings posted under the account “Clarke Pharmaceuticals”; your YouTube channel directs consumers to your website www.clarkepharmaceuticals.com to purchase your products. Clarke, M.D., PhD. and used in the treatment of his patients with debilitating and degenerative neurologic injuries.” On your webpage at www.clarkepharmaceuticals.com titled “What is Neupanex®” “Neupanex® is the result of 25 years of research by Lewis Clarke, M.D., Ph.D. . . . When he began treating patients with debilitating neurologic diseases such as strokes, spinal cord injuries, Guillian-Barre [sic], and degenerative neurologic processes such as MS, ALS, Alzheimer’s, and Parkinson’s, he began implementing interventional and neuroregenerative neuropharmacology.” “Clinically, many of Dr. Cognitive and socialization improvements in dementias and improvements in motor deficits and paralysis have all been demonstrated. …It can be used in athletes as an aide to neuroprotection, especially after a concussive injury.” On your webpage at www.clarkepharmaceuticals.com titled “Video Testimonials of Neupanex®”: “Can a 6 year old traumatic brain injury be effectively reversed?” “When a parent has dementia . . . NFL wide receivers sustain an average of 49 concussions during a regular season. …This ultimately leads to CTE (chronic traumatic encephalopathy), with the same symptoms of dementia or Alzheimer’s disease. … This is Courtney and his wife Candace’s testimonial as to how Neupanex® has helped him heal both physically and emotionally from repetitive head trauma.” “Using Neupanex® to address dementia … Bill Turner started exhibiting the warning signs for early onset dementia … His wife Toni . . . called Dr.
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
- 908d1a4b14b6
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.
Sources, dates, and coverage →