REGULATORY INTELLIGENCE·Recall
Zydus Pharmaceuticals Recalls Nelarabine Injection Nationwide Over Impurity Failures: Critical Supply Chain Impact
Zydus Pharmaceuticals USA Inc. has initiated a nationwide Class II recall (D-0256-2025) for 1,893 vials of Nelarabine Injection due to failed impurity/degradation specifications. This voluntary action, impacting critical oncology supply, necessitates immediate assessment by procurement and regulatory teams. Businesses must evaluate supply chain resilience and enhance quality assurance protocols to mitigate risks from such product quality deviations.
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