Drug Enforcement D-0027-2025

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

Status

Ongoing

Classification

Class II

Report Date

November 6, 2024

Termination Date

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Product Information

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.
Product quantity
35880 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide.

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0027-2025
Event ID
95500
Recall initiation date
October 9, 2024
Center classification date
October 28, 2024
Code info
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.
More code info
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