FDA Recall D-0534-2023

Ascend Laboratories, LLC · Parsippany, NJ

Class II Ongoing 1157 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.

Quantity: 12,804 bottles

Reason for recall

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Recall record

Recall number: D-0534-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2023-03-14
Classified by FDA Center: 2023-04-13
FDA published: 2023-04-05
Recalling firm: Ascend Laboratories, LLC
Firm location: Parsippany, NJ

Drug identification

Brand name(s): DABIGATRAN ETEXILATE
Generic name(s): DABIGATRAN ETEXILATE
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-474, 67877-475, 67877-624
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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