FDA-Drug2026-04-22Class II
Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02
Cipla USA, Inc.
Hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Sold states
Nationwide in the USA
Affected count
63,192 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2026Original summary
Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02 CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 Distribution: Nationwide in the USA Affected quantity: 63,192 bottles
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