Dabigatran Etexilate Capsules Recalled Due to Nitrosamine Impurity

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Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated to reduce the risk of stroke and blood clots.

Ascend Laboratories LLC has voluntarily recalled 10 lots of Dabigatran Etexilate Capsules, USP 75mg and 150mg due to the presence of a nitrosamine impurity, N-nitroso-dabigatran, above the Food and Drug Administration’s (FDA) acceptable daily limit.

The recalled lots were distributed nationwide to wholesalers, distributors, and retailers in the US from June 2022 to October 2022:

  • Dabigatran Etexilate Capsules, USP 75mg; NDC Number 67877-474-60; Lots: 22142462 (Expiration Date May 2024), 22142463 (Expiration Date May 2024), 22142464 (Expiration Date May 2024), 22143000 (Expiration Date June 2024), 22143001 (Expiration Date June 2024), 22143002 (Expiration Date June 2024)
  • Dabigatran Etexilate Capsules, USP 150mg; NDC Number 67877-475-60; Lots: 22142448 (Expiration Date May 2024), 22142449 (Expiration Date May 2024), 22142450 (Expiration Date May 2024),  22143845 (Expiration Date July 2024)

The recalled products are supplied in 60-count bottles.

Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation in adults; for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults; to reduce the risk of recurrence of DVT and PE in adults who have been previously treated; and for the prophylaxis of DVT and PE in adults following hip replacement surgery.

Long-term use of a product containing a nitrosamine impurity above an acceptable level may be associated with an increased risk of cancer. To date, the Company has not received any reports of adverse events related to this recall. 

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

References:

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. News release. Ascend Laboratories LLC. Accessed March 24, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg#recall-announcement.