REGULATORY INTELLIGENCE·Recall
Park Avenue Compounding Recalls Fentanyl Citrate/Ropivacaine Due to CGMP Deviations
Park Avenue Compounding has initiated a Class II recall (D-0178-2026) for 189 bags of Fentanyl citrate / Ropivacaine combination, a Schedule II controlled substance, distributed in Missouri. The recall stems from Current Good Manufacturing Practice (CGMP) deviations, specifically a revised interpretation of Acceptable Quality Level (AQL) results. This event highlights critical compliance risks in sterile compounding, necessitating immediate review of quality control protocols for pharmaceutical procurement and regulatory compliance teams.
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