85%Confidence
0Views
FDASource
2026-03-22Date
Summary
Cipla's recall of Nilotinib Capsules due to stability failures indicates potential supply chain disruptions for this oncology drug, which could affect patient access and treatment continuity. This Class III recall suggests quality control issues at the manufacturing site, potentially impacting Cipla's reputation and regulatory standing in the US market.
Actionable: Monitor Cipla's manufacturing compliance and consider alternative suppliers for Nilotinib to mitigate supply risks.
AI Confidence: 85%
Data Points
firmCipla USA, Inc.
classificationClass III
statusOngoing
distributionU.S.A. Nationwide
productNilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc
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