Dabigatran etexilate capsule recall overview:
- Who: Ascent Laboratories LLC recalled certain 75 mg and 150 mg capsules of anticoagulant dabigatran etexilate.
- Why: The pills may contain more nitrosamine than the Acceptable Daily Intake level.
- Where: Ascent Laboratories distributed the pills throughout the United States to wholesalers, retailers and distributors between June 2022 and October 2022.
Ascent Laboratories LLC issued a recall for certain packages of its 75 mg and 150 mg capsules of the anticoagulant dabigatran etexilate.
The United States Food and Drug Administration (FDA) published the recall because those packages could include pills that contain more than the Acceptable Daily Intake level of nitrosamine, which is known to cause cancer for those who are exposed to high levels of the drug over an extended period of time.
The recall of dabigatran etexilate with elevated nitrosamine applies to 60-capsule bottles with expiration dates of May, June and July 2024 that have National Drug Code number 67877-475-60 and are from 150 mg capsule bottles from lots 22142448, 22142449, 22142450 or 22143845. The recall also involves 75 mg bottles of 22142462, 22142463, 22142464, 22143000, 22143001 or 22143002.
Wholesalers, retailers should stop distributing product immediately, dabigatran etexilate recall says
Ascent Laboratories LLC says it has not received any reports of effects related to the elevated nitrosamine recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.
“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,” the recall notice says.
Consumers can call Ascent Laboratories about the dabigatran etexilate recall at 877-272-7901 at any time. Issues with the pills can be reported to the FDA’s MedWatch Adverse Event Reporting program online or by downloading and printing the form. Consumers can also call (800) 332-1088 to request a reporting form.
Elevated nitrosamine was also an issue with Lupin Pharmaceuticals Inc.’s quinapril tablets, which were recalled in December.
Are you affected by the dabigatran etexilate recall? Let us know in the comments.
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