Class II
Ongoing
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
This recall is currently active, issued August 7, 2024. It was issued by Fdc Limited.
- Company
- Fdc Limited
- Recall Initiated
- July 23, 2024
- Posted
- August 7, 2024
- Recall Number
- D-0623-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 66,528 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
- Official Source
- View on FDA website ↗
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
U.S. A. Nationwide
Lot / Code Info
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
More recalls by Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC L...
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May 14, 2025 · Class II
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed b...
Mar 26, 2025 · Class II
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