What happened
Original notice title
Suprimo Imports MARCS-CMS 657631, June 22, 2023
From the archived source record
As described below, these products are unapproved new drugs 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, these products are misbranded drugs 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 “AK Forte” contains the undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and methocarbamol. 1 Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. In addition, the undeclared dexamethasone in “AK Forte” may cause serious side effects when combined with other medications. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. The undeclared diclofenac ingredient in “AK Forte” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Unapproved New Drugs “AK Forte” and “Bob Marley CannaKing” 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 Drugs Your “AK Forte” 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 “AK Forte” does not declare that the product contains the drug ingredients diclofena
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
- 13b242e25978
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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