FDA-Drug2024-05-29Class III

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Release Testing: Out of specification for particulate matter test.

Sold states
TX, PA
Affected count
35,069 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
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

Official notice

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

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