What happened
Original notice title
Everymarket Inc. MARCS-CMS 688348, August 27, 2024
From the archived source record
As described below, “Vail-Bon Jie Yang Wan” and “Ossos-Sans” are unapproved new drugs introduced or delivered for introduction into interstate commerce 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, “Vail-Bon Jie Yang Wan” is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce 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 “Vail-Bon Jie Yang Wan” contains undeclared dexamethasone and chlorpheniramine. 1 Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events. Unapproved New Drugs Your “Vail-Bon Jie Yang Wan” and “Ossos-Sans” products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Misbranded Drug Your “Vail-Bon Jie Yang Wan” 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 “Vail-Bon Jie Yang Wan” does not declare that the product contains the drug ingredients dexamethasone and chlorpheniramine.
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
- cd6ec81c523d
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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