Drug recall D-0282-2025

Class II Ongoing reported Mar 26, 2025

Product

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

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

Lots and codes

Lot: 084A067, Exp 12/31/2025

Recall details

Recalling firm
FDC Limited, Aurangabad, Maharashtra State, N/A
Quantity
90960 bottles
Distribution
Nationwide in the U.S
Type
Voluntary: Firm initiated
Recall initiated
March 11, 2025

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