Drug recall
Esmolol Hydrochloride Injection, 100 mg/10mL (10 mg/mL), 10 mL single dose vial, Rx only, NDC 63323-652-10…
FDA recall event 36480 · Class III · Abraxis Pharmaceutical Products
Key facts
| Event ID | 36480 |
|---|---|
| Recall numbers | D-391-7 |
| Recalling firm | Abraxis Pharmaceutical Products |
| Product type | Drugs |
| Products | Esmolol Hydrochloride Injection, 100 mg/10mL (10 mg/mL), 10 mL single dose vial, Rx only, NDC 63323-652-10. American Pharmaceutical Partners, Inc., Schaumburg, IL 60173 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed total impurity specification. |
| Initiation date | Sep 22, 2006 |
| Termination date | Jul 16, 2007 |
| City | Rosemont |
| State | IL |
| Country | United States |
| FEI number | 3005734179 |
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