Drug recall D-0502-2024

Class III Ongoing reported May 29, 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.

Lots and codes

Lot #: HAD3383A, Exp 8/31/2024

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
35,069 bottles
Distribution
TX, PA
Type
Voluntary: Firm initiated
Recall initiated
April 22, 2024

Related products