What happened
Original notice title
Great India Overseas Pvt. Ltd. dba Silkrute MARCS-CMS 729065, June 17, 2026
From the archived source record
Based on our review, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” are unapproved new drugs under sections 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, “ProGlan Capsules” is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), 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). Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” products are drugs under 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. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Misbranded Drug Violations “ProGlan Capsules” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product label and/or website include a statement that misleadingly suggests that the drug product is approved or endorsed by FDA in some way. The product labeling for “ProGlan Capsules” includes an image of the FDA logo accompanied by the claim “APPROVED.” This assertion misleadingly suggests that “ProGlan Capsules” is approved or endorsed by FDA in some way. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading.
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
- 867abe8aec89
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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