Drug recall
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun…
FDA recall event 94465 · Class III · SUN PHARMACEUTICAL INDUSTRIES INC
Key facts
| Event ID | 94465 |
|---|---|
| Recall numbers | D-0502-2024 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Product type | Drugs |
| Products | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Release Testing: Out of specification for particulate matter test. |
| Initiation date | Apr 22, 2024 |
| Report date | May 29, 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: