Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Cipla USA, Inc.
- Affected product
- USA Nationwide
- Risk or reason
- cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Remedy or action
- Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
- Official ID
- D-0661-2026