Drug Enforcement D-0129-2025

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Status

Ongoing

Classification

Class II

Report Date

December 18, 2024

Termination Date

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Product Information

Product description
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
Product quantity
1971 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Ascend Laboratories, LLC
Address
339 Jefferson Rd Ste 101

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0129-2025
Event ID
95896
Recall initiation date
December 12, 2024
Center classification date
December 12, 2024
Code info
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
More code info
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