Drug product
Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02
D-0449-2026
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 98670
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 113,336 bottles
- Official record key
drug-enforcement:D-0449-2026
Official wording
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Code information: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations