Dabigatran Etexilate Capsules recall: reason, affected lot number, and all you need to know

Ascend Laboratories LLC. recalled Dabigatran Etexilate Capsules over concerns about nitrosamine impurities (Image via FDAreport.com)
Ascend Laboratories LLC. recalled Dabigatran Etexilate Capsules over concerns about nitrosamine impurities (Image via FDAreport.com)

Ascend Laboratories LLC. has recently issued a nationwide recall of Dabigatran Etexilate Capsules. USP 75 mg and 150 mg over concerns about the presence of nitrosamine (N-Nitroso-Dabigatran). It is feared that the concerned capsules contain nitrosamines above the established Acceptable Daily Intake (ADI) level.

The recalled Dabigatran Etexilate Capsules. USP 75 mg and 150 mg are used as an oral anticoagulant to help lower the risk of stroke and blood clots. However, the Nitrosamine impurities present in the capsules can make them potentially harmful for patients. As of now, neither the Ascend Laboratories LLC nor the United States Food and Drug Administration (FDA) have received reports of any incidents or fatalities caused in regards to the use of the recalled capsules.

People who are exposed to Nitrosamines above acceptable levels over long periods of time have an increased risk of suffering from cancer. While Nitrosamnines are common in water and food, including cured and grilled meats, dairy products, and vegetables, they must not be consumed above acceptable levels over long periods of time.


Customers feeling uneasiness following the use of Dabigatran Etexilate Capsules should contact their health care provider immediately

The recall affects select lots of the Dabigatran Etexilate Capsules. USP 75 mg and 150 mg that were produced and distributed across the country by Ascend Laboratories LLC. of New Jersey. Packed in labeled boxes, the affected capsules were sold all across the United States.

Customers may have bought the recalled capsules from major pharmacies, retailers, and online stores across the country. The concerned product lots were distributed nationwide to wholesalers, distributors, and retailers between June 2022 and October 2022.

The recalled Dabigatran Etexilate Capsules. USP 75 mg and 150 mg were produced and distributed by Ascend Laboratories LLC. of New Jersey (Image via FDAreport.com)
The recalled Dabigatran Etexilate Capsules. USP 75 mg and 150 mg were produced and distributed by Ascend Laboratories LLC. of New Jersey (Image via FDAreport.com)

Customers can recognize the recalled products by looking for the following details on the boxes:

ProductNDCLot NumberExpiration DatePresentationConfiguration/Count
Dabigatran Etexilate Mesylate Caps 150 Mg67877-475-6022142448MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 150 Mg67877-475-6022142449MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 150 Mg67877-475-6022142450MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg67877-475-6022142462MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg67877-475-6022142463MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg67877-475-6022142464MAY.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg67877-475-6022143000JUN.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg 67877-475-60 22143001 JUN.2024

HDPE Bottles

60 capsules/bottle
Dabigatran Etexilate Mesylate Caps 75 Mg 67877-475-60 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

Consumers who may have been using the recalled capsules can continue using them for the time being. However, one should contact their physician for advice regarding an alternative at the earliest possible date. Patients who happen to feel any sort of uneasiness or problems following the use of the recalled capsules should contact or visit their health care provider for a quick medical inspection.

The company is advising wholesalers, distributors, and pharmacists to recall all distributed stocks of the capsules and to quarantine the product with immediate effect. Customers with doubts and queries about the Dabigatran Etexilate Capsules recall can get in touch with Ascend Laboratories LLC. of New Jersey at 877- 272-7901, 24 hours, all throughout the week.

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