FDA Drug Class II — Moderate

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

Hazard

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

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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.
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.

Units Affected

10584 bottles

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