Drug product
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
D-0226-2026
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 97974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12,576 bottles
- Official record key
drug-enforcement:D-0226-2026
Official wording
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Code information: Lot 5PB0183, exp 1/31/2027
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
nitrosamine impurity
-
Manufacturing or process control
CGMP Deviations