What happened
Original notice title
Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club MARCS-CMS 652780, April 27, 2023
From the archived source record
As described below, this product is an unapproved new drug sold 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). Furthermore, your “PrimeZEN Black 6000” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your product contains undeclared pharmaceutical ingredients. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Unapproved New Drugs Your “PrimeZEN Black 6000” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Misbranded Drugs Your “PrimeZEN Black 6000” product is also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. Your “PrimeZEN Black 6000” product, which contains undeclared tadalafil and sildenafil, is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, your “PrimeZEN Black 6000” product is misbranded under section 502(f)(1) of the FD&C Act. Additionally, your “PrimeZEN Black 6000” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “PrimeZEN Black 6000” produc
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
- 55bff4a02096
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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