Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

March 22, 2023

Audience: Health Professional, Pharmacy, Consumer

March 22, 2023 – Parsippany. New Jersey. 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 belov,:. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022.

ProductNDCLot
Number
Expiration
Date
PresentationConfiguration
/Count
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-6022142448MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-6022142449MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-6022142450MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022142462MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022142463MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022142464MAY.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022143000JUN.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022143001JUN.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 75 Mg
67877-474-6022143002JUN.2024HDPE
Bottles
60
capsules/bottle
Dabigatran Etexilate
Mesylate Caps 150
Mg
67877-475-6022143845JUL.2024HDPE
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 CenterContact InformationArea of Support
Ascend Laboratories, LLC877-272-7901, 24 hrs., 7 days a weekTo 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.

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

Source: Ascend Laboratories LLC

Original Source: https://www.drugs.com/fda/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg-14588.html

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