John McCarthy
By: Virgin Islands Free Press News Desk
ST. CROIX — Federal health officials have issued a nationwide public health alert following a massive voluntary recall of nearly 300,000 capsules of a widely prescribed blood thinner due to product degradation and impurity concerns.
The U.S. Food and Drug Administration (FDA) announced that Alkem Laboratories Ltd. voluntarily pulled three lots—totaling 5,460 cartons (299,520 capsules)—of Dabigatran Etexilate Capsules, the generic equivalent of the popular anticoagulant Pradaxa. The affected medication was distributed across the United States by Major Pharmaceuticals.
According to FDA enforcement reports, the recall was initiated after 12-month stability testing showed the drug failed impurity and degradation specifications. Specifically, testing revealed elevated levels of multiple degradation impurities above acceptable safety thresholds.
What You Need to Know
Dabigatran is a direct oral anticoagulant prescribed to prevent blood clots and lower the risk of stroke in patients with atrial fibrillation, deep vein thrombosis, and pulmonary embolisms.
Because abruptly stopping blood-thinning medication can trigger a stroke or life-threatening blood clot, health officials strongly advise patients NOT to stop taking their prescribed medication without consulting their doctor or pharmacist first to arrange a safe alternative.
Recalled Product Details
Patients and local pharmacy customers should check their prescription bottles for the following affected details:
- Medication: Dabigatran Etexilate Capsules (Generic Pradaxa)
- Distributor: Major Pharmaceuticals
- Dosages Affected: 150 mg (60-count blister packs) and 75 mg (30-count and 60-count blister packs)
- Lot Numbers:
251415832514158525141586
- Expiration Date: April 30, 2027
If you suspect you have medication from one of the recalled lots, contact your pharmacy or prescribing physician immediately to get a replacement prescription.
