Cinacalcet Tablet, Film Coated
FDA Recall NDC 16729-441
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 16729-441). 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 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: 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
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
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
16729-440-10Product
16729-440-15Product
16729-440-01Product
16729-441-10Product
16729-441-15Product
16729-441-01Product
16729-442-10Product
16729-442-15Product
16729-442-01Product
Class II Ongoing
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
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
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
16729-440-10Product
16729-440-15Product
16729-440-01Product
16729-441-10Product
16729-441-15Product
16729-441-01Product
16729-442-10Product
16729-442-15Product
16729-442-01Product
Class II Ongoing
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
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
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
16729-440-10Product
16729-440-15Product
16729-440-01Product
16729-441-10Product
16729-441-15Product
16729-441-01Product
16729-442-10Product
16729-442-15Product
16729-442-01Product
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.
