Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8
Summary
The FDA issued a Class II for Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30 by Aurobindo Pharma USA Inc. Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.
Details
Source
Drug Recall
External ID
D-0078-2025
Action Date
2024-12-11
Status
Ongoing
Category
drug
Product Description
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Lot/Code Info: Lot #: a) CFSB23001A, Exp 03/31/2025, CFSB23002A, Exp 07/31/2025; CFSB23003A, Exp 10/31/2025; CFSB23004A, Exp 10/31/2025; b) P2300196, 12/31/2024
Quantity Affected: 3336 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: 2024-11-07
Company
East Windsor, 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 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 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 (Aurobindo Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc have FDA actions?
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0078-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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