Xelpros Solution/ Drops
FDA Recall NDC 47335-317
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Xelpros (NDC 47335-317). A significant event, classified as Class III, was initiated on Apr 22, 2024 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Release Testing: Out of specification for particulate matter test."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Release Testing: Out of specification for particulate matter test.
Apr 22, 2024
May 29, 2024
35,069 bottles
Recall Profile & Regulatory Data
Event ID
94465
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TX, PA
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
Batch or Lot Expiration Information
Lot# : HAD3383A, Exp 8/31/2024
Affected Packages Involved in this Recall
47335-317-90Product
47335-317-98Product
47335-317-92Product
47335-317-94Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
