Drug Enforcement D-0182-2025

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

January 15, 2025

Termination Date

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Product Information

Product description
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, 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
136,181 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
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

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

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0182-2025
Event ID
96014
Recall initiation date
December 16, 2024
Center classification date
January 3, 2025
Code info
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
More code info
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