Drug Enforcement D-0502-2024

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

Status

Ongoing

Classification

Class III

Report Date

May 29, 2024

Termination Date

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Product Information

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
Product quantity
35,069 bottles
Reason for recall
Failed Release Testing: Out of specification for particulate matter test.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
TX, PA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0502-2024
Event ID
94465
Recall initiation date
April 22, 2024
Center classification date
May 20, 2024
Code info
Lot #: HAD3383A, Exp 8/31/2024
More code info
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