Drug recall
Aldactone (spironoloactone) tablets USP 50 mg, 100 Count Bottle, Rx only, Distributed by G.D. Searle LLC…
FDA recall event 58408 · Class III · Pfizer Pharmaceuticals LLC
Key facts
| Event ID | 58408 |
|---|---|
| Recall numbers | D-510-2011 |
| Recalling firm | Pfizer Pharmaceuticals LLC |
| Product type | Drugs |
| Products | Aldactone (spironoloactone) tablets USP 50 mg, 100 Count Bottle, Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1041-31 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent (Single Ingredient Drug): Above specification for spironoloactone assay at 18 months stability time point. |
| Initiation date | Apr 4, 2011 |
| Termination date | Sep 23, 2013 |
| City | Caguas |
| State | PR |
| Country | United States |
| FEI number | 2623450 |
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