Drug Enforcement D-1172-2023

Subpotent: Out of Specification result observed for low assay

Status

Terminated

Classification

Class III

Report Date

September 27, 2023

Termination Date

February 13, 2024

Product Information

Product description
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
Product quantity
69,707 cartons
Reason for recall
Subpotent: Out of Specification result observed for low assay
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide wide in the USA

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-1172-2023
Event ID
93006
Recall initiation date
September 7, 2023
Center classification date
September 20, 2023
Code info
Lot# 10026, Lot 10027, Exp. 09/2023.
More code info
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