Reported Mar 26, 2025 · Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma…
FDC Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FDC Limited · B-8 MIDC Industrial Area · Aurangabad, Maharashtra State, N/A · N/A
Is this the product you have?
- Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only
- Distributed byLeading Pharma LLC, Fairfield, NJ
- Manufactured byFDC Limited, Maharashtra, India, NDC 69315-308-05
- Lot codes and dates
- Lot
084A067Exp 12/31/2025
- Lot
- Amount recalled
- 90960 bottles
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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