Drug recall
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle…
FDA recall event 66124 · Class II · Pfizer Us Pharmaceutical Group
Key facts
| Event ID | 66124 |
|---|---|
| Recall numbers | D-014-2014 |
| Recalling firm | Pfizer Us Pharmaceutical Group |
| Product type | Drugs |
| Products | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently… |
| Initiation date | Sep 4, 2013 |
| Report date | Nov 27, 2013 |
| Termination date | Apr 13, 2017 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 3000292881 |
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: