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
Product description
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Lot numbers, UPCs & expiration codes
Lot 201900 Expiration Date: JAN 2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-067-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 5, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 8,381 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-067-2013, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 63630
- Address
- 1809 Wilson Rd
- Code information
- Lot 201900 Expiration Date: JAN 2015
- Postal code
- 43228-9579
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-067-2013
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- 8,381 bottles
- Termination date
- Sep 18, 2013
- Reason for recall
- Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2012