Drug Enforcement D-0282-2025

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Status

Ongoing

Classification

Class II

Report Date

March 26, 2025

Termination Date

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Product Information

Product description
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Product quantity
90960 bottles
Reason for recall
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S

Location & Firm

Recalling firm
FDC Limited
Address
B-8 MIDC Industrial Area, Waluj District

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0282-2025
Event ID
96495
Recall initiation date
March 11, 2025
Center classification date
March 17, 2025
Code info
Lot: 084A067, Exp 12/31/2025
More code info
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