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 |
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