Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02
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 #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
- Official ID
- D-0675-2026