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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Recall Number D-067-2013
Classification Class II
Code Info Lot 201900 Expiration Date: JAN 2015
Product Distributed Qty 8,381 bottles
Reason For Recall Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

Event Detail

Event Id 63630
Product Type Drugs
Status Ongoing
Recalling Firm Boehringer Ingelheim Roxane Inc
City Columbus
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide