Xelpros (latanoprost ophthalmic emulsion) 0.005%…

Date

May 29, 2024

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Ongoing

Filed by

Sun Pharmaceutical Industries Inc

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

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

Distribution pattern

TX, PA

Quantity

35,069 bottles

Codes and lots

Lot #: HAD3383A, Exp 8/31/2024

Recall started

April 22, 2024

Recall number

D-0502-2024

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0502-2024. The agency record governs; check it and the company before acting.