FDA WARNING_LETTER - International Pharmaceutical Corporation

The FDA issued a Warning Letter to Som Pruthi International Pharmaceutical Corporation/Pilex Corporation after reviewing their websites (malaria.me.uk, arthritis.bz, hepatitis.bz, pilex.com, and hernorrhoids.com). The agency determined that the products Malariam, Arthritan, Hepatan, and Pilex are promoted with therapeutic claims for conditions such as malaria, arthritis, hepatitis, and hemorrhoids, which cause them to be unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act. These products are not generally recognized as safe and effective for their intended uses and lack prior FDA approval, violating section 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) because their labeling fails to bear adequate directions for use. The FDA requires prompt corrective action within fifteen working days, including a written response detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in enforcement actions such as product seizure and injunctions.