Cinacalcet Tablet, Film Coated
FDA Recall NDC 16729-440
Latest: Class II · Status: Terminated · Initiated Oct 10, 2024 · 3 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Cinacalcet (NDC 16729-440). A significant event, classified as Class II, was initiated on Oct 10, 2024 by Accord Healthcare, Inc.. The reported reason for this action was: "CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Oct 10, 2024
Nov 06, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95501
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Termination Date
Sep 23, 2026
Product Description
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Batch or Lot Expiration Information
Lot# a)
Lot# : Expiry Date: M2303264 01/2026 b)
Lot# : Expiry Date: M2306979 04/2026
Affected Packages Involved in this Recall
16729-440-10Cinacalcet
16729-440-15Cinacalcet
16729-440-01Cinacalcet
16729-441-10Cinacalcet
16729-441-15Cinacalcet
16729-441-01Cinacalcet
16729-442-10Cinacalcet
16729-442-15Cinacalcet
16729-442-01Cinacalcet
Class II Terminated
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Oct 10, 2024
Nov 06, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95501
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Termination Date
Sep 23, 2026
Product Description
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Batch or Lot Expiration Information
Lot# a)
Lot# : Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b)
Lot# : Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026
Affected Packages Involved in this Recall
16729-440-10Cinacalcet
16729-440-15Cinacalcet
16729-440-01Cinacalcet
16729-441-10Cinacalcet
16729-441-15Cinacalcet
16729-441-01Cinacalcet
16729-442-10Cinacalcet
16729-442-15Cinacalcet
16729-442-01Cinacalcet
Class II Terminated
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Oct 10, 2024
Nov 06, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95501
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Termination Date
Sep 23, 2026
Product Description
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Batch or Lot Expiration Information
Lot# a)
Lot# : Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b)
Lot# : Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025
Affected Packages Involved in this Recall
16729-440-10Cinacalcet
16729-440-15Cinacalcet
16729-440-01Cinacalcet
16729-441-10Cinacalcet
16729-441-15Cinacalcet
16729-441-01Cinacalcet
16729-442-10Cinacalcet
16729-442-15Cinacalcet
16729-442-01Cinacalcet
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.
