This 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, which may impair the quality of Pradaxa. Patients may not receive a fully effective dose of Pradaxa 75mg, which would increase his or her risk of experiencing an ischemic stroke.
The affected lot has an NDC 0597-0149-54, Lot #201900, and an expiration date of January 2015. It is recommended for patients to continue taking the product as directed until they obtain replacement to assure there is no interruption of therapy. Pharmacists who may have dispensed Pradaxa capsules to patients are instructed to contact those patients to return the affected product lot back to the pharmacy. Patients with questions regarding their current Pradaxa prescription bottle can contact their pharmacist to verify if the tablets are from the affected lot.
Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
For more information call (877) 319-8963 or visit www.pradaxa.com.