A voluntary recall has been issued by Ascend Laboratories, LLC for specific lots of Dabigatran Etexilate Capsules (a generic substitute for Pradaxa) due to detection of an impurity within the medication. It has been found that a dangerous level of a nitrosamine called N-nitroso-dabigatran, a substance known to cause cancer is present in the drug. At the time of the writing of this notice, no adverse reactions have been reported but patients are being cautioned to follow proper procedures if their stock of medication is affected.
SUMMARY
Date of Recall:
Announced: March 22, 2023
Public Notification: March 22, 2023
Name(s) of Drug:
Dabigatran Etexilate
Company Name:
Ascend Laboratories, LLC
Drug Indication:
Atrial Fibrillation
Deep Vein Thrombosis (DTV)
Pulmonary Embolism (PE)
Prevention of Blood Clots in those who present a high risk
Product Description
The drug is distributed by licensed pharmacies in white, plastic bottles. Information regarding lot number, NDC number, expiration date and count-per-bottle can be located on the label. All affected lots are contained within the 75mg and 150mg capsule distributions.
Reason for Recall
The particular lots involved in the recall have been found to contain a dangerously high level of the nitrosamine, N-nitroso-dabigatran, a substance that has been found to increase the risk of cancer. While the nitrosamine is not dangerous in small doses, continued exposure is not recommended.
Impacts
Consumers may not experience any noticeable symptoms if their medication is affected. However, it is important to participate in the recall if your drug is listed as continued use can increase the risk of cancer.
Lot information
Consumers should locate the bottle in which the medication comes to compare NDC and lot numbers as well as expiration dates with the chart below. If you find your NDC number, lot number and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to take part in recall procedures and ensure that your health is not affected.
| Product | NDC | Lot Number |
Expiration Date |
Presentation | Configuration /Count |
| Dabigatran Etexilate Mesylate Caps 150 Mg |
67877-475-60 | 22142448 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 150 Mg |
67877-475-60 | 22142449 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 150 Mg |
67877-475-60 | 22142450 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22142462 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22142463 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22142464 | MAY.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22143000 | JUN.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22143001 | JUN.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 75 Mg |
67877-474-60 | 22143002 | JUN.2024 | HDPE Bottles |
60 capsules/bottle |
| Dabigatran Etexilate Mesylate Caps 150 Mg |
67877-475-60 | 22143845 | JUL.2024 | HDPE Bottles |
60 capsules/bottle |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.
DO NOT DISCONTINUE USE UNTIL ADVISED BY YOUR PHYSICIAN TO DO SO.
Discontinuation of this medication may put you at risk for clotting due to underlying conditions.
If you find that your lot of medication is part of this recall, do the following:
- Call your doctor right away. Ask for a new prescription to replace your recalled medication.
- Consumers may contact Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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