One Lot of Pradaxa Recalled
A single lot of Pradaxa 75 mg has been recalled due to a possible packaging defect which may cause moisture to get into the bottle, thereby affecting the safety and effectiveness of the drug. The affected lot belongs to:
- NDC 0597-0149-54
- Lot #201900
- Expiration date: January 2015
MPR reports that Boehringer Ingelheim, the manufacturer of the anti-stroke drug, issued the nationwide recall because the quality of the drugs might be impaired, which could expose patients to an elevated risk of experiencing an ischemic stroke.
Pradaxa is used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) or arrhythmic heart beat.
Consumers can verify with their pharmacist if their tablets belong to the affected lot. Pharmacists who have sold Pradaxa (dabigatran etexilate mesylate) bottles have been asked to contact patients to ask them to return the bottle to the pharmacy, reports MPR.
Patients should continue taking the product as directed until they obtain replacement medication.