FDA-Drug2012-12-05Class II

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

Boehringer Ingelheim Roxane Inc
Hazard

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

Sold states
Nationwide
Affected count
8,381 bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

Official notice

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

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