Patients who use Pradaxa (dabigatran etexilate mesylate) Capsules are being strongly urged to keep their medication in their original packaging only. 

Who: Dabigatran etexilate mesylate

What: Pradaxa, a blood thinner (anticoagulant) known as a direct thrombin inhibitor

Why: Pradaxa should only be kept in the original manufacturer bottle with the original cap (not in regular amber colored pharmacy vials).  Once opened, the pills must be used within 60 days or be discarded.

More Details On Pradaxa Recall

FDA is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only be dispensed and stored in the original bottle or blister package.

BACKGROUND: Pradaxa is an anticoagulant (blood thinner) medication known as a direct thrombin inhibitor. The Pradaxa label and Medication Guide contain information about these special storage and handling requirements, but FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies.

RECOMMENDATION: Pharmacists should only dispense Pradaxa in the original manufacturer bottle with the original dessicant cap. Do not repackage Pradaxa capsules in standard amber pharmacy vials. Patients should not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. Open only one bottle of Pradaxa at a time. Once the bottle is opened, the product must be used within 60 days. Read the Medication Guide for Pradaxa for more information about these special storage and handling requirements.