On November 5, 2012, Boehringer Ingleheim issued a patient-level recall of Pradaxa® 75 mg capsules NDC # 00597-0149-54.
This recall was issued due to a potential packaging defect that may compromise the bottle integrity. There are some members who may have filled affected product from Aetna Rx Home Delivery.
How to check if you have affected product
This recall affects lot number 201900 exp. 01/15. To see if you have affected product, please check the lot number. The lot number can be found on the top flap of the box or on the back of the manufacturer’s label. If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots, please return it to the pharmacy that filled your prescription.
Where to call if you have questions
If you are using product that is affected by this recall, talk to your doctor. He or she is familiar with your medical history and can:
If you have questions about your prescription drug benefits or product you ordered from Aetna Rx Home Delivery - Call Rx Member Services toll-free at 1-888-RX AETNA (1-888-792-3862).
If you have questions about this recall - Call Boehringer Ingleheim toll-free at 1-800-542-6257 and select option 3 or visit www.pradaxa.com. You may also call the U.S. Food and Drug Administration toll-free at 1 888 INFO-FDA (1 888-463-6332).You can also always call the toll-free number on your Aetna member ID card.