Cinacalcet Tablet
FDA Recall NDC 43598-367
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 43598-367). A significant event, classified as Class II, was initiated on Oct 09, 2024 by Dr. Reddys Laboratories Inc. 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
Oct 09, 2024
Nov 06, 2024
10584 bottles
Recall Profile & Regulatory Data
Event ID
95500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Batch or Lot Expiration Information
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Affected Packages Involved in this Recall
43598-367-30Product
43598-367-05Product
43598-368-30Product
43598-368-05Product
43598-369-30Product
43598-369-05Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Oct 09, 2024
Nov 06, 2024
35880 bottles
Recall Profile & Regulatory Data
Event ID
95500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
43598-367-30Product
43598-367-05Product
43598-368-30Product
43598-368-05Product
43598-369-30Product
43598-369-05Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Oct 09, 2024
Nov 06, 2024
285126 bottles
Recall Profile & Regulatory Data
Event ID
95500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
Product Description
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Batch or Lot Expiration Information
Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026
Affected Packages Involved in this Recall
43598-367-30Product
43598-367-05Product
43598-368-30Product
43598-368-05Product
43598-369-30Product
43598-369-05Product
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.
