What happened
Original notice title
DSE Healthcare Solutions, LLC
From the archived source record
Our inspection revealed significant violations of Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Unapproved New Drugs and Misbranded New Drugs In January 2017, we reviewed your product labels for several of your products, including Urinozinc Prostate Health Formula and Prelief, and we reviewed your websites at the internet addresses www.dsehealthcare.com, www.prelief.com and www.urinozinc.com, where you take orders for and/or where you provide links to a website from which consumers can purchase these products. URINOZINC may be right for you” Prelief: On the product label: • “Taking Prelief . . . can often stop [foods] from causing painful bladder symptoms” On your website www.prelief.com, which is listed on your product label and where there are links to buy the product: • “Urinary Urgency and Bladder Discomfort Caused By Foods” • “Prelief has found special uses in the diets of individuals with food acid-aggravated conditions that can result in urinary bladder problems.” • “Independent urology studies from major researchers and hospital conclude the following . . .
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 5bcd249c811d
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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