Cinacalcet Tablet, Film Coated
FDA Recall NDC 65862-832
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Cinacalcet (NDC 65862-832). A significant event, classified as Class II, was initiated on Nov 07, 2024 by Aurobindo Pharma Limited. The reported reason for this action was: "cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Nov 07, 2024
Dec 11, 2024
3336 bottles
Recall Profile & Regulatory Data
Event ID
95730
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
65862-831-30Product
65862-831-90Product
65862-831-01Product
65862-831-05Product
65862-832-30Product
65862-832-90Product
65862-832-01Product
65862-832-05Product
65862-833-30Product
65862-833-90Product
65862-833-01Product
65862-833-05Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Nov 07, 2024
Dec 11, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95730
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
Batch or Lot Expiration Information
Lot# : a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024
Affected Packages Involved in this Recall
65862-831-30Product
65862-831-90Product
65862-831-01Product
65862-831-05Product
65862-832-30Product
65862-832-90Product
65862-832-01Product
65862-832-05Product
65862-833-30Product
65862-833-90Product
65862-833-01Product
65862-833-05Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Nov 07, 2024
Dec 11, 2024
102576 bottles
Recall Profile & Regulatory Data
Event ID
95730
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Batch or Lot Expiration Information
Lot# : a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024
Affected Packages Involved in this Recall
65862-831-30Product
65862-831-90Product
65862-831-01Product
65862-831-05Product
65862-832-30Product
65862-832-90Product
65862-832-01Product
65862-832-05Product
65862-833-30Product
65862-833-90Product
65862-833-01Product
65862-833-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
