US-based Boehringer Ingelheim Pharmaceuticals has announced the recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules in the US and Puerto Rico over packaging issue.
The recall of Pradaxa, 75mg 60 US, NDC 0597- 0149-54, with lot number 201900 and expiry date of January 2015 is being conducted due to a potential packaging defect that may compromise the integrity of the bottle.
According to the company, moisture can easily get into a damaged bottle and may harm the capsule quality.
As a result, a patient may not receive accurate dose of Pradaxa and can increase his or her risk of experiencing an ischemic stroke.
Boehringer Ingelheim Pharmaceuticals is the US subsidiary of Boehringer Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies.