Published recall report · ImpurityUpdated · 1 yr 9 mo ago
Ascend Laboratories, LLC recall: Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
- Producer
- Ascend Laboratories, LLC
- Brand
- DABIGATRAN ETEXILATE
24142328
- Dates on pack
- Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
0367877624600
0367877474601
0367877475608
More detail
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
In the news
Reporting from news publishers. Follow the official notice for product advice.
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