Recalls / Class II
Class IID-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.
- Brand name
- Dabigatran Etexilate
- Generic name
- Dabigatran Etexilate
- Active ingredient
- Dabigatran Etexilate Mesylate
- Route
- Oral
- NDCs
- 67877-474, 67877-475, 67877-624
- FDA application
- ANDA208040
- Affected lot / code info
- Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
Why it was recalled
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 13,560 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-03-14
- FDA classified
- 2023-04-13
- Posted by FDA
- 2023-04-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0533-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.