FDAHealthJuly 23, 2024
FDC Limited — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 23, 2024
U.S. A. Nationwide
What's affected?
- Product
- 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.
- Brand
- CIPROFLOXACIN
- UPC
- 0369315308028
- Lot code
- a)
Additional details
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 66,528 bottles.
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