REGULATORY INTELLIGENCE·Recall
FDA Initiates Class III Recall for Rising Pharma's Diflorasone Diacetate Ointment Due to Impurity Failures
Rising Pharma Holdings, Inc. has initiated a Class III recall (D-0599-2024) for 868 tubes of Diflorasone Diacetate Ointment, USP, 0.05%, due to failed impurity specifications at 12-month stability testing. This nationwide recall, impacting lot DI2303B, underscores critical quality control vulnerabilities for pharmaceutical procurement and regulatory affairs teams. Businesses must assess supply chain continuity and review quality assurance protocols for topical corticosteroid products.
90-Day Activity