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🏥 FDA: Cipla USA, Inc. — Class III

healthcarebearishSource: FDA
85%Confidence
0Views
FDASource
2026-03-20Date

Summary

Cipla's Nilotinib Capsules recall due to stability failures indicates potential quality control issues at their manufacturing site, which could impact patient safety and regulatory trust. This may lead to increased scrutiny from the FDA and potential supply disruptions for this oncology medication.

Actionable: Monitor Cipla's manufacturing compliance and consider alternative suppliers for Nilotinib if quality concerns persist.

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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