Drug recall
A-Hydrocort (Hydrocortisone Sodium Succinate) for Injection, USP, 100 mg, Sterile Powder for Injection…
FDA recall event 51096 · Class II · Hospira Inc.
Key facts
| Event ID | 51096 |
|---|---|
| Recall numbers | D-416-2009, D-417-2009, D-418-2009 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | A-Hydrocort (Hydrocortisone Sodium Succinate) for Injection, USP, 100 mg, Sterile Powder for Injection packaged in a single-dose vial, Hydrocortisone Activity/2 mL (when mixed), Rx only, NDC…, Sterile Vancomycin Hydrochloride, USP, For Intravenous Use, Sterile Powder packaged in a flip top vial, Equivalent to 1 g Vancomycin, Lyophilized, 10 units per immediate carton, 5 cartons per shipping…, Sterile Vancomycin Hydrochloride USP, Sterile Lyophilized Powder, Equivalent to 5 g Vancomycin, Pharmacy Bulk Package (100-ml vials)-Not for Direct Infusion, For Intravenous Use, NDC 0409-6509-01, Rx… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The sterility of the stoppers used on sterile products was potentially compromised. |
| Initiation date | Feb 25, 2009 |
| Termination date | Aug 25, 2011 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3005579246 |
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