90%Confidence
3Views
FDASource
2026-05-02Date
Summary
Cipla USA recalls cinacalcet tablets due to N-Nitroso impurity above safe limits, a serious quality issue that may lead to regulatory penalties and market share loss. This adds to industry concerns about nitrosamine contamination in generic drugs.
Actionable: Reduce exposure to Cipla and monitor for similar nitrosamine issues in other generic manufacturers.
AI Confidence: 90%
Data Points
firmCipla USA, Inc.
classificationClass II
statusOngoing
distributionNationwide in the USA
productCinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla
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