Reported Dec 5, 2012 · Terminated
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim…
Boehringer Ingelheim Roxane Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
- Lot codes and dates
- Lot 201900 Expiration DateJAN 2015
- Amount recalled
- 8,381 bottles
Where it was sold
- Nationwide
Why it was recalled
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
This product could cause temporary or reversible health problems — stop using it.
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