REGULATORY INTELLIGENCE·Warning Letter
FDA Mandates Class II Recall for Chattem Inc's Unisom SleepMelts Due to Nitrosamine Impurity
Chattem Inc initiated a Class II recall for 180,696 cartons of Unisom SleepMelts (Diphenhydramine HCl tablets) due to nitrosamine impurities exceeding FDA limits, stemming from CGMP deviations at manufacturer Adare Pharmaceuticals, Inc. This nationwide USA recall underscores critical supply chain vulnerabilities and heightened regulatory scrutiny on nitrosamine control, demanding immediate action from procurement and regulatory affairs to reassess supplier compliance and product quality.
90-Day Activity