FDA-Drug2024-11-06Class II
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Dr. Reddy's Laboratories, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Sold states
USA Nationwide.
Affected count
10584 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2025Don't want to check this manually?
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