Drug recall
Midazolam HCl Injection, 5mg/5mL (1 mg/mL), 5mL Vials, Rx only, For IM or IV Use Only, Baxter Healthcare…
FDA recall event 37745 · Class II · Baxter
Key facts
| Event ID | 37745 |
|---|---|
| Recall numbers | D-800-2007 |
| Recalling firm | Baxter |
| Product type | Drugs |
| Products | Midazolam HCl Injection, 5mg/5mL (1 mg/mL), 5mL Vials, Rx only, For IM or IV Use Only, Baxter Healthcare Corp., by: MOVA Pharma Corp., Caguas, Puerto Rico |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; leaking closure and white crusted powder near neck of the vial |
| Initiation date | Apr 10, 2007 |
| Termination date | Dec 11, 2007 |
| City | New Providence |
| State | NJ |
| Country | United States |
| FEI number | 3002998048 |
At a glance
- 1–9 Products in this recall
- None 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