US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 5, 2012 (14 years ago)

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

What was recalled

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

Recalling firm
Boehringer Ingelheim Roxane Inc
NDC code
0597-0149-54
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-067-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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