Drug recall
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC…
FDA recall event 89665 · Class II · B. Braun Medical, Inc.
Key facts
| Event ID | 89665 |
|---|---|
| Recall numbers | D-0655-2022 |
| Recalling firm | B. Braun Medical, Inc. |
| Product type | Drugs |
| Products | 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of sterility assurance: leaking bags |
| Initiation date | Feb 25, 2022 |
| Report date | Mar 23, 2022 |
| Termination date | Mar 16, 2023 |
| City | Allentown |
| State | PA |
| Country | United States |
| FEI number | 2523676 |
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 · Source date: