RPK Pharmaceuticals Inc. – FDA Warning Letter, Apr 6, 2021

The FDA issued a Warning Letter to Rich Mangini on March 26, 2021 (WL # 1663) regarding drug listing deficiencies for "clotrimazole and betamethasone dipropionate cream" (NDC 53002-9740). The FDA's review of the firm's electronic Drug Registration and Listing System (eDRLS) submission revealed that the provided label image states "triamcinolone 0.1 % ointment," which does not match the listed product name, "clotrimazole and betamethasone dipropionate cream." These are distinct drug products with different active ingredients.

This discrepancy constitutes a violation of Section 510(j)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires firms to include the correct label for listed drugs. The FDA previously notified the firm of these deficiencies on April 13, 2020, and subsequently removed the product from the FDA's Online NDC Directory on May 28, 2020, due to continued non-compliance.

Failure to fulfill listing obligations is a prohibited act under Section 301(p) of the FD&C Act and renders the drug misbranded under Section 502(o), violating Section 301(a). The FDA emphasizes that accurate drug listing information is crucial for patient safety, drug establishment