REGULATORY INTELLIGENCE·Recall
Lupin Pharmaceuticals Initiates Class II Recall for Ganirelix Acetate Injection Over Impurity Concerns
Lupin Pharmaceuticals, Inc. initiated a Class II recall for 32,736 vials of Ganirelix Acetate Injection (ANDA216075) due to out-of-specification impurities. This voluntary action, impacting distribution in FL, MA, MI, and OH, highlights critical quality control vulnerabilities at the manufacturing site, Lupin Limited in Nagpur, India. Procurement and regulatory teams must assess current inventory, evaluate supply chain resilience for Ganirelix Acetate, and proactively identify alternative qualified suppliers to mitigate potential disruptions and ensure patient access.
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