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FDARecalled Nov 6, 2024 · #D-0027-2025

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Classification: Class II Distribution: USA Nationwide.

Product details

Product
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Type
Drugs
Manufacturer
Dr. Reddy's Laboratories, Inc.
Model numbers
T2200698
UPCs