Drug recall
Octreotide Acetate Injection, 500 mcg/mL (0.5 mg/mL); an Rx subcutaneous injection long-acting octapeptide…
FDA recall event 38487 · Class III · Abraxis Pharmaceutical Products
Key facts
| Event ID | 38487 |
|---|---|
| Recall numbers | D-986-2007 |
| Recalling firm | Abraxis Pharmaceutical Products |
| Product type | Drugs |
| Products | Octreotide Acetate Injection, 500 mcg/mL (0.5 mg/mL); an Rx subcutaneous injection long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin; 1 mL single… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an error on the vial label that incorrectly indicates the product concentration is 0.05 mg/mL octreotide acetate when the actual concnetration is 0.5 mg/mL. |
| Initiation date | Aug 2, 2007 |
| Termination date | Jan 9, 2008 |
| City | Rosemont |
| State | IL |
| Country | United States |
| FEI number | 3005734179 |
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