Warning letterFDA · Jun 17, 2026
Great India Overseas Pvt. Ltd. dba Silkrute MARCS-CMS 729065, June 17, 2026
Named company: Great India Overseas Pvt. Ltd. dba Silkrute
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).…
Lot information: not specified in this record.