REGULATORY INTELLIGENCE·Product Recall
OurPharma LLC Terminates Class III Recall for Superpotent HYDROmorphone HCl
OurPharma LLC has concluded a Class III voluntary recall (D-0385-2025) for 1,375 cassettes of superpotent HYDROmorphone Hydrochloride 50mg/50mL, manufactured at its Fayetteville, AR facility. This event, initiated April 15, 2025, and terminated March 6, 2026, highlights critical quality control vulnerabilities in compounded sterile products. Procurement and regulatory teams must scrutinize supplier potency testing protocols to mitigate supply chain risks.
90-Day Activity
OurPharma LLCHydromorphone Hydrochloride
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2025-04-30