FDA Drug recall D-0534-2023
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
- FDA Drug
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed… by Ascend Laboratories, citing CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0534-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-14 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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.
Reason
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Identifiers
| ndc | 67877-475-60 |
|---|---|
| ndc | 67877-474-60 |
| ndc | 67877-624-60 |
| ndc | 67877-624-31 |
| code_info | Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Ascend Laboratories
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laborator…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
All Ascend Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0534-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.