Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Reported: April 5, 2023 Initiated: March 14, 2023 #D-0534-2023
Product Description
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Reason for Recall
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 12,804 bottles
- Distribution
- Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.. Recalled by Ascend Laboratories, LLC. Units affected: 12,804 bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2023. Severity: Moderate. Recall number: D-0534-2023.
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