Drug recall
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ…
FDA recall event 66791 · Class III · Sandoz Inc
Key facts
| Event ID | 66791 |
|---|---|
| Recall numbers | D-341-2014 |
| Recalling firm | Sandoz Inc |
| Product type | Drugs |
| Products | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions. |
| Initiation date | Nov 6, 2013 |
| Report date | Dec 18, 2013 |
| Termination date | May 29, 2014 |
| City | Wilson |
| State | NC |
| Country | United States |
| FEI number | 3000210731 |
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 · Source date: