Drug recall
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet…
FDA recall event 93816 · Class II · Ascend Laboratories, LLC
Key facts
| Event ID | 93816 |
|---|---|
| Recall numbers | D-0339-2024 |
| Recalling firm | Ascend Laboratories, LLC |
| Product type | Drugs |
| Products | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specification: Out of specification for organic impurities |
| Initiation date | Jan 16, 2024 |
| Report date | Feb 28, 2024 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3004459274 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: