NDC 47335-600
Cinacalcet 90 mg tablet, film coated
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #: DNE0702A, Exp. 06/30/2026
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, film coated, oral
- Strength
- 90 mg
- Approval
- ANDA ANDA207008
- On the market since
- May 15, 2019
- Package NDCs
47335-600-83- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2021
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