Drug product
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
D-0450-2026
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 98670
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 96,096 bottles
- Official record key
drug-enforcement:D-0450-2026
Official wording
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Code information: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations