Boehringer Ingelheim Pharmaceuticals has issued a voluntary recall of 75-mg dose dabigatran (Pradaxa), citing a potential packaging defect.
The recall involves a single manufacturing lot of dabigatran: 75 mg 60 US, NDC 0597- 0149-54, lot 201900, with an expiration date of January 2015. Boehringer said the recall is due to a potential packaging defect that may compromise the bottle integrity. A damaged bottle could allow moisture to get into the bottle, possibly impair the quality of drug and consequently reduce its effectiveness.
The recall is restricted to the U.S. and Puerto Rico.
Dabigatran is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Patients who do not receive a fully effective dose potentially would have an increased risk of experiencing an ischemic stroke.
Pharmacists have been alerted about the recall and instructed to contact patients to return the product lot back to the pharmacy. Ridgefield, Conn.-based Boehringer said patients should continue to take the product as directed until they obtain replacement to assure there is no interruption of therapy. It added that it believes most of the potentially affected bottles have been returned, but if a patient has or receives a bottle of dabigatran 75 mg from the lot, then he or she should return the bottle to a pharmacist as soon as possible for replacement at no charge.