News | Antiplatelet and Anticoagulation Therapies | March 24, 2023

Ascend Laboratories Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules Due to the Detection of NDMA Impurity

The product is used as an oral anticoagulant to lower the risk of stroke and blood clots 

The recalled product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

March 24, 2023 — According to the U.S. Food and Drug Administration (FDA), Ascend Laboratories LLC is voluntarily recalling Dabigatran Etcxilate capsules USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall. 

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. 

The product is used as an oral anticoagulant to lower the risk of stroke and blood clots. 

The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are indicated in the table belovow. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022. 

 

Product 

NDC 

Lot
Number 

Expiration
Date 

Presentation 

Configuration
/Count 

Dabigatran Etexilate
Mesylate Caps 150
Mg 

67877-475-60 

22142448 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 150
Mg 

67877-475-60 

22142449 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 150
Mg 

67877-475-60 

22142450 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22142462 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22142463 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22142464 

MAY.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22143000 

JUN.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22143001 

JUN.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 75 Mg 

67877-474-60 

22143002 

JUN.2024 

HDPE
Bottles 

60
capsules/bottle 

Dabigatran Etexilate
Mesylate Caps 150
Mg 

67877-475-60 

22143845 

JUL.2024 

HDPE
Bottles 

60
capsules/bottle 

 

Wholesalers/distributors and pharmacies with an existing inventory of the lots listed in the table above, should stop use and distribution and quarantine the product immediately. 

Wholesalers and Distributors are advised to recall the distributed product. Please notify any accounts or additional locations that may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Ascend requests that they immediately cease distribution of the affected product. 

Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. 

Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information. 

 

Contact Center 

Contact Information 

Area of Support 

Ascend Laboratories, LLC 

877-272-7901, 24 hrs., 7 days a week 

To report adverse events and
product complaints 

 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 7 days a week. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 

Complete and submit the report Online: www.fda.gov/medwatch/report.htm 

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 

Related Pradaxa Anticoagulant Content: 

FDA Clears Pradaxa as First Oral Anticoagulant for Children 

First Head-to-Head Comparison of Novel Oral Anticoagulants in Matched Population for Costs, Resource Utilization 

Pradaxa Shows Low Bleeding, Stroke Rates in GLORIA-AF Registry 

Advantages and Disadvantages of Novel Oral Anticoagulants 

FDA Approves First Reversal Agent for Pradaxa 

Real-World Analysis Reinforces Safety, Effectiveness of Dabigatran in Routine Clinical Care 

Find more news on anticoagulation therapies 


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