Drug recall D-0451-2026
Product
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
Reason for recall
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lots and codes
Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
Recall details
- Recalling firm
- Cipla USA, Inc., Warren, NJ
- Quantity
- 63,192 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 16, 2026
Related products
- Cinacalcet – drug information
- NDC 69097-410 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Cipla USA Inc.
- NDC 69097-412 Cinacalcet · Cinacalcet Hydrochloride 90 mg/1 · Cipla USA Inc.
- NDC 69097-411 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Cipla USA Inc.