FDA recall D-0502-2024

Product

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

TX, PA

Key facts

Status

Ongoing

Initiation date

2024-04-22

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0502-2024