Thrive Health and Wellness, LLC dba Thrive Health Solutions
Thrive Health and Wellness, LLC dba Thrive Health Solutions (Englewood, CO), owned by Doug Hatch, received an FDA Warning Letter following a March–April 2025 inspection that found serious sterility deficiencies in the repackaging of drug products including NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections. The firm conducted aseptic operations outside certified ISO 5 areas, used non-sterile gloves and wipes, had carpeted flooring in processing areas, and never performed media fills, rendering products adulterated under FDCA section 501(a)(2)(A). The products were also cited as unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1); the firm voluntarily ceased repackaging and initiated a recall of all affected products dispensed between January 2 and April 18, 2025. FDA warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (3)
The drug products you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL, are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.
You do not have any FDA-approved applications on file for the drug products that you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL.
NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL
Required actions (4)
on May 21, 2025, your firm initiated a voluntary recall of all repackaged sterile drug products dispensed between January 2, 2025, to April 18, 2025, due to a lack of sterility assurance.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of sterile drug products not intended for immediate use.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future.
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