What happened
Original notice title
MS Bionic 5/3/17
From the archived source record
Based on our inspection and review of your product labels, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA obtained a sample of your product, “Megajex.” As described below, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 355(a) and 331(d)]. Specifically, FDA confirmed through laboratory analysis that a sample of your “Megajex” product contains the following undeclared active pharmaceutical ingredients: Product Name Undeclared Active Pharmaceutical Ingredient(s) Megajex sildenafil; tadalafil Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED). Misbranded Drug “Megajex” contains two PDE-5 inhibitors. Therefore, “Megajex” is prescription drug as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or potentiality for harmful effect, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. As such, “Megajex”is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because its labeling fails to bear adequate directions for its intended uses. Because no FDA-approved applications are in effect for your product, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 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. According to section 201(n) of the Act [21 U.S.C. § 321(n)], in determining whether the labeling or advertising “is misleading, there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations . . ..” The labeling for your “Megajex” fai
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
- 3309b6500eb7
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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