D-0502-2024 Class III Ongoing
FDA drug recall D-0502-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Apr 22, 2024 and is designated Class III. Reason for recall: Failed Release Testing: Out of specification for particulate matter test. The recall status is ongoing. Affected quantity: 35,069 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2024
- Initiation Date
- Apr 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,069 bottles
Product 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
Reason for Recall
Failed Release Testing: Out of specification for particulate matter test.
Distribution Pattern
TX, PA
Code Information
Lot #: HAD3383A, Exp 8/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0502-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026