Dabigatran Etexilate Capsule, Coated Pellets
FDA Recall NDC 67877-474
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Dabigatran Etexilate (NDC 67877-474). A significant event, classified as Class II, was initiated on Dec 12, 2024 by Ascend Laboratories, Llc. The reported reason for this action was: "CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above 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-Dabigatran impurity above recommended interim limit
Dec 12, 2024
Dec 18, 2024
1971 bottles
Recall Profile & Regulatory Data
Event ID
95896
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Batch or Lot Expiration Information
Lot# : 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
Affected Packages Involved in this Recall
67877-475-60Product
67877-474-60Product
67877-624-60Product
67877-624-31Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Dec 12, 2024
Dec 18, 2024
10,444 bottles
Recall Profile & Regulatory Data
Event ID
95896
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
Batch or Lot Expiration Information
Lot# : 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026
Affected Packages Involved in this Recall
67877-475-60Product
67877-474-60Product
67877-624-60Product
67877-624-31Product
Class II Ongoing
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Mar 14, 2023
Apr 05, 2023
13,560 bottles
Recall Profile & Regulatory Data
Event ID
91880
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.
Batch or Lot Expiration Information
Lot# s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
Affected Packages Involved in this Recall
67877-475-60Product
67877-474-60Product
67877-624-60Product
67877-624-31Product
Class II Ongoing
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Mar 14, 2023
Apr 05, 2023
12,804 bottles
Recall Profile & Regulatory Data
Event ID
91880
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Batch or Lot Expiration Information
Lot# s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
Affected Packages Involved in this Recall
67877-475-60Product
67877-474-60Product
67877-624-60Product
67877-624-31Product
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.
