Drug recall
Pediatric Atropine Sulfate Injection, USP, 0.05 mg/mL; Single Dose, NDC 0409-9630-05, Hospira, Inc., Lake…
FDA recall event 59817 · Class II · Hospira Inc.
Key facts
| Event ID | 59817 |
|---|---|
| Recall numbers | D-677-2012 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | Pediatric Atropine Sulfate Injection, USP, 0.05 mg/mL; Single Dose, NDC 0409-9630-05, Hospira, Inc., Lake Forest, IL 60045 USA. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products; OOS result for total impurities at the 8 month stability testing interval. |
| Initiation date | Aug 5, 2011 |
| Termination date | May 6, 2014 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3004591926 |
At a glance
- 1–9 Products in this recall
- 10–99 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