⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite

DrugsSource: FDA (drug) · Date: 2025-12-17

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Cipla USA, Inc.
Product
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Reason / hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the US
Recall initiated
2025-11-14
Code info
Lot 5PB0164, exp 1/31/2027
Product quantity
15,744 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Warren
State
NJ
Country
United States
Event id
97974
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