Boehringer Ingelheim Pharmaceuticals is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015.
Pradaxa is used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
The recall is being conducted due to a potential packaging defect on this lot that may compromise the bottle integrity. A damaged bottle could allow moisture to get into the bottle and, thus, may impair the quality of Pradaxa.
As a consequence a patient may not receive a fully effective dose of Pradaxa 75mg, which would increase his or her risk of experiencing an ischemic stroke. Boehringer says the risk is small -- not zero. Therefore Pradaxa is being recalled at the patient level as a precautionary measure.
Actions for patients
Patients should continue to take the product as directed until they obtain replacement to assure there is no interruption of therapy.
The company says it believes most of the potentially affected bottles have been returned, but if a person has or receives a bottle of Pradaxa 75mg from the potentially affected lot he should return it to the pharmacist as soon as possible for replacement at no charge.
Information has been sent to pharmacists alerting them of the details pertaining to this recall. As described in the recall communications, pharmacists who may have dispensed Pradaxa capsules to patients from manufacturing lot 201900 are instructed to contact those patients to return the product lot back to the pharmacy.
Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.