FDAFDA · Food and drugs·Recall number D-067-2013
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Published December 5, 2012 · Recall initiated: November 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- Nationwide
- Lot
- Lot 201900 Expiration Date: JAN 2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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