What happened
Original notice title
Empire Distributors, Inc. MARCS-CMS 575029, April 10, 2019
From the archived source record
The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, “Rhino Black 5K Plus.” 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 (“the Act”) [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, the product is a misbranded drug under section 502 of the Act [21 U.S.C. § 352] and sold in violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. FDA confirmed through laboratory analysis that a sample of your “Rhino Black 5K Plus” contains the undeclared active pharmaceutical ingredients sildenafil and tadalafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors. 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 Drug “Rhino Black 5K Plus” is a drug as defined by section 201(g)(1) of the 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 Drug Your “Rhino Black 5K Plus” also is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for this drug fails to bear adequate directions for use. For these reasons, “Rhino Black 5K Plus” is misbranded under section 502(f)(1) of the Act. Additionally, under section 502(a) of the 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 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 “Rhino Black 5K Plus” does not declare that it contains sildenafil and tadalafil.
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
- 754298d4bda6
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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