Class II
Ongoing
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
- Company
- Fdc Limited
- Recall Initiated
- March 11, 2025
- Posted
- March 26, 2025
- Recall Number
- D-0282-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 90960 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
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
Distribution
Nationwide in the U.S
Lot / Code Info
Lot: 084A067, Exp 12/31/2025
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