Drug recall
Oxygen Compressed U. S. P. UN 1072, Gas: 7782-44-7, Oxygen 2, is stored in B, C, D and E-size tanks, Rx only…
FDA recall event 53986 · Class II · Special Care Home Oxygen & Medical Equipment, Inc
Key facts
| Event ID | 53986 |
|---|---|
| Recall numbers | D-367-2010 |
| Recalling firm | Special Care Home Oxygen & Medical Equipment, Inc |
| Product type | Drugs |
| Products | Oxygen Compressed U. S. P. UN 1072, Gas: 7782-44-7, Oxygen 2, is stored in B, C, D and E-size tanks, Rx only. Manufacturer by Special Care Home Oxygen & Medical Equipment, Inc., 1236 Executive Drive… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations:Oxygen product has no purity test documentation and cylinder labels did not reflect current address of the manufacturer. |
| Initiation date | Nov 23, 2009 |
| Termination date | Apr 28, 2010 |
| City | Richardson |
| State | TX |
| Country | United States |
| FEI number | 3002520593 |
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