Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,
Summary
The FDA issued a Class II for Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories I by Dr. Reddy's Laboratories, Inc.. Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.
Details
Source
Drug Recall
External ID
D-0027-2025
Action Date
2024-11-06
Status
Ongoing
Category
drug
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.
Lot/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.
Quantity Affected: 35880 bottles
Reason for Recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-09
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0027-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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