Source: FDA · September 1, 2026 · Ongoing · Official government notice
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Nationwide within the United States
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Nationwide within the United States