Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Srikakulam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 20, 2022 · 5 inspections |
Recalls
- Oct 9, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots: Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, … - Oct 9, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots: Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026. - Oct 9, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots: Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
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
- Strength
- 90 mg
- Approval
- ANDA ANDA208368
- On the market since
- Sep 18, 2020
- Package NDCs
43598-369-0543598-369-30- Official label
- DailyMed (National Library of Medicine), updated Apr 5, 2024
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