Multi-event March 2023 FDA Recall Dabigatran Etexilate by Ascend Laboratories, Llc
This Multi-event Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on March 14, 2023 for the product Dabigatran Etexilate. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0533-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
03-14-2023
04-05-2023
13,560 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.
Batch or Lot Expiration Information
Lot# s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
Affected Packages Involved in this Recall
Recall Number: D-0534-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
03-14-2023
04-05-2023
12,804 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
