Drug recall
Heparin Sodium in 0.9% Sodium Chloride Injection, 1,000 units (2 Units/mL), 500 mL IV bag, Rx only, B. Braun…
FDA recall event 57085 · Class II · B. Braun Medical Inc
Key facts
| Event ID | 57085 |
|---|---|
| Recall numbers | D-123-2011, D-124-2011 |
| Recalling firm | B. Braun Medical Inc |
| Product type | Drugs |
| Products | Heparin Sodium in 0.9% Sodium Chloride Injection, 1,000 units (2 Units/mL), 500 mL IV bag, Rx only, B. Braun Medical Inc, Irvine, CA USA 92614-5895, NDC 0264-9872-10, Heparin Sodium in 5% Dextrose Injection, 25,000 units (50 Units/mL), 500 mL IV bag, Rx only, B. Braun Medical Inc, Irvine, CA USA 92614-5895, NDC 0264-9577-10 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Substance: The recall was initiated after B. Braun Medical Inc. (B. Braun) was notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of… |
| Initiation date | Oct 27, 2010 |
| Termination date | Mar 9, 2012 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2021236 |
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