CLASS II Drug recall · Reported 5 Dec 2012 · FDA Enforcement Report
Pradaxa (dabigatran etexilate) recalled by Boehringer Ingelheim Roxane
Boehringer Ingelheim Roxane is recalling Pradaxa (dabigatran etexilate), distributed nationwide in the US. The recall was initiated on 5 Nov 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-067-2013
- FDA event ID
- 63630
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2012
- FDA classified
- 26 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 5 Nov 2012 | Recall initiated by company | |
| 26 Nov 2012 | Classified by FDA | +21 days |
| 5 Dec 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Product as listed by the FDA
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Which lots are affected?
Lot 201900 Expiration Date: JAN 2015
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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