Drug recall
Compressed Medical Oxygen USP in A, C, D and E steel cylinders, Rx only, Manufactured by Sound Oxygen Service…
FDA recall event 55619 · Class II · Sound Oxygen Service, Inc.
Key facts
| Event ID | 55619 |
|---|---|
| Recall numbers | D-604-2010 |
| Recalling firm | Sound Oxygen Service, Inc. |
| Product type | Drugs |
| Products | Compressed Medical Oxygen USP in A, C, D and E steel cylinders, Rx only, Manufactured by Sound Oxygen Service, 4108 B Place NW, Auburn, WA 98001. Each cylinder is identified with four labels which… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Lack of documentation that prefill, fill and/or post-fill testing of cylinders and finished products was performed. |
| Initiation date | Apr 29, 2010 |
| Termination date | Aug 3, 2011 |
| City | Auburn |
| State | WA |
| Country | United States |
| FEI number | 3007372598 |
At a glance
- 1–9 Products in this recall
- 1–9 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