LATANOPROST Recall D-0502-2024
Description: 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
LATANOPROST Recall D-0502-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0502-2024 |
| Event ID | 94465 |
| Brand | XELPROS |
| Generic Name | LATANOPROST |
| Manufacturer | LATANOPROST |
| Original Package? | 1 |
| Active Substance | LATANOPROST |
| Drug Route | OPHTHALMIC |
| Distribution | TX, PA |
| Quantity | 35,069 bottles |
| Recall Reason | Failed Release Testing: Out of specification for particulate matter test. |
| Drug Classification | Class III |
| Drug Code Info | 20240529 |
| Product NDC | 47335-317 |
| Product NUI | N0000175454 M0017805 |
| Pharma Class (EPC) | Prostaglandin Analog [EPC] |
| Pharma Class (CS) | Prostaglandins [CS] |
| Recall Initiation Date | 20240422 |
| Report Date | 20240529 |
| Classification Date | 20240520 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6Z5B6HVF6O |
| Drug Application Number | NDA206185 |
| Structured Product Labeling (SPL ID) | c866d64c-e5c1-4ae5-b023-957d0211581d |
| Structured Product Labeling (SPL Set ID) | 34ad5cf6-4df0-4104-bddd-4c7631133ded |
| Similar To |