Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ascent Pharmaceuticals Inc | Central Islip, NY, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyAug 9, 2024 · 9 inspections |
| Cipla Limited | Raigad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 4, 2024 · 7 inspections |
Recalls
- Jun 29, 2026 · Class II · Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lots: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027 - Jun 29, 2026 · Class II · Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lots: Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027 - Jun 29, 2026 · Class II · Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lots: Lot #: 5PB0563, Exp 4/30/2027 - Mar 16, 2026 · Class II · Cipla USA, Inc.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lots: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027 - Mar 16, 2026 · Class II · Cipla USA, Inc.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lots: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 - Mar 16, 2026 · Class II · Cipla USA, Inc.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Lots: Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 - Nov 14, 2025 · Class II · Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots: Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027 - Nov 14, 2025 · Class II · Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots: Lot 5PB0164, exp 1/31/2027 - Nov 14, 2025 · Class II · Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots: Lot 5PB0183, exp 1/31/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cinacalcet: every company that makes it
- Form
- tablet, oral
- Strength
- 60 mg
- Approval
- ANDA ANDA208915
- On the market since
- Mar 8, 2018
- Package NDCs
69097-411-02- Official label
- DailyMed (National Library of Medicine), updated Dec 12, 2025
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