FDA Drug recall D-0159-2023
Rasagiline Mesylate Tablets 1 mg
- FDA Drug
- Class II
- terminated
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of Rasagiline Mesylate Tablets 1 mg by Ascend Laboratories, citing presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0159-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-28 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, PR, RI, TN, TX, WA, WI |
Product
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Identifiers
| ndc | 67877-259-30 |
|---|---|
| ndc | 67877-260-30 |
| code_info | Lot # 22140903. Exp. Dec. 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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-0159-2023%22
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