Recalling firm
Ascend Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2024-12-18
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
1971 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
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
Code / lot info
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.