FDA recall D-067-2013

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-11-05

Report date

2012-12-05

Termination date

2013-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-067-2013