Drug recall
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc…
FDA recall event 91228 · Class I · Accord Healthcare, Inc.
Key facts
| Event ID | 91228 |
|---|---|
| Recall numbers | D-0131-2023 |
| Recalling firm | Accord Healthcare, Inc. |
| Product type | Drugs |
| Products | Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial |
| Initiation date | Nov 29, 2022 |
| Report date | Jan 25, 2023 |
| Termination date | Feb 22, 2024 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3007518432 |
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: