NEW YORK (AP) — Boehringer Ingelheim said Wednesday it is recalling a single manufacturing lot of its anticlotting drug Pradaxa because the bottle may be defective.
The German drugmaker said it is recalling one production lot of 75-milligram Pradaxa capsules with an expiration date of January 2015. Boehringer Ingelheim said there is a defect in the packaging that could allow moisture to get into the bottle, reducing the effectiveness of the drug.
Pradaxa is approved to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation, a type of irregular heartbeat.
The company said it believes most of the bottles that could have the defect have been returned. However, it said patients who have a bottle of Pradaxa with the lot number 201900 and the Jan. 2015 expiration date should return the bottle to their pharmacist as soon as possible so they can get a replacement at no charge. Boehringer Ingelheim said patients should continue taking Pradaxa as directed until they get a replacement bottle to make sure their treatment is not interrupted.