FDA Drug Class II — Moderate

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

Hazard

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

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Products

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Brand
Boehringer Ingelheim Roxane Inc
UPC
Lot 201900 Expiration Date: JAN 2015

Units Affected

8,381 bottles

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