Drug recall D-0533-2023
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.
Reason for recall
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lots and codes
Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Parsippany, NJ
- Quantity
- 13,560 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 14, 2023
Related products
- Dabigatran Etexilate – drug information
- NDC 67877-475 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 150 mg/1 · Ascend Laboratories, LLC
- NDC 67877-624 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 110 mg/1 · Ascend Laboratories, LLC
- NDC 67877-474 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 75 mg/1 · Ascend Laboratories, LLC