NDC 67877-749
Fosfomycin Tromethamine 3 g granule, for solution
On the label: Ascend Laboratories, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Baddi Solan, India | Makes it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Recalls
- Jan 16, 2024 · Class II · Ascend Laboratories, LLC
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Lots: lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024. - Jul 18, 2023 · Class III · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Lots: Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fosfomycin: every company that makes it
- Form
- granule, for solution, oral
- Strength
- 3 g
- Approval
- ANDA ANDA214554
- On the market since
- Oct 22, 2021
- Package NDCs
67877-749-57- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2025
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