D-0502-2024Class III

SUN PHARMACEUTICAL INDUSTRIES INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-05-29

Distribution

TX, PA

Firm state

Product quantity

35,069 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

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

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

Code / lot info

Lot #: HAD3383A, Exp 8/31/2024

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See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →