FDAHealthMarch 11, 2025
FDC Limited — 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
⚠️ 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
- March 11, 2025
Nationwide in the U.S
What's affected?
- 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
- Brand
- CIPROFLOXACIN
- UPC
- 0369315308028
- Lot code
- 084A067
Additional details
Lot: 084A067, Exp 12/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 90960 bottles.
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