Drug Enforcement D-067-2013

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

Status

Terminated

Classification

Class II

Report Date

December 5, 2012

Termination Date

September 18, 2013

Product Information

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
Product quantity
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
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Boehringer Ingelheim Roxane Inc
Address
1809 Wilson Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-067-2013
Event ID
63630
Recall initiation date
November 5, 2012
Center classification date
November 26, 2012
Code info
Lot 201900 Expiration Date: JAN 2015
More code info
—