FDA Drug recall D-1145-2023
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Dist…
- FDA Drug
- Class III
- terminated
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class III recall of Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Dist… by Ascend Laboratories, citing failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1145-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-07-18 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Identifiers
| ndc | 67877-749-57 |
|---|---|
| code_info | Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523,…Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1145-2023%22
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