Drug recall
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries…
FDA recall event 92725 · Class III · SUN PHARMACEUTICAL INDUSTRIES INC
Key facts
| Event ID | 92725 |
|---|---|
| Recall numbers | D-1082-2023 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Product type | Drugs |
| Products | Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Out of Specification result observed in content uniformity testing |
| Initiation date | Jul 18, 2023 |
| Report date | Aug 16, 2023 |
| Termination date | Feb 26, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3013472760 |
At a glance
- 1–9 Products in this recall
- 10–99 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: