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Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ...

FDA Recall #D-0027-2025 — Class II — October 9, 2024

Recall #D-0027-2025 Date: October 9, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

35880 bottles

Distribution

USA Nationwide.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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