FDC Limited recalls 5mL Ciprofloxacin Ophthalmic Solution bottles due to cap stuck in nozzle. Rx only product with specific lot number. Contact for return instructions.
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
FDC Limited is recalling 5mL Ciprofloxacin Ophthalmic Solution bottles because the cap can get stuck in the nozzle, making it impossible to use the solution. This affects people who need prescription eye drops and could lead to improper medication use.
The cap's spike can get lodged in the nozzle, preventing the solution from being dispensed. This means the eye drop bottle cannot be used properly, potentially leading to incorrect medication application.
People with a prescription for Ciprofloxacin Ophthalmic Solution (0.3% in 5mL bottles) from FDC Limited. Those who have the specific lot number 084A067 are most at risk.
Check for the 5mL bottle labeled 'Ciprofloxacin Ophthalmic Solution USP 0.3%'. Look for the lot number 084A067 on the bottle. This product was distributed by Leading Pharma and manufactured by FDC Limited in India.
Look for the lot number 084A067 on the bottle to confirm if it's affected.
The product is not safe to use as the cap can get stuck in the nozzle, making it impossible to dispense the solution.
Check for the 5mL bottle labeled 'Ciprofloxacin Ophthalmic Solution USP 0.3%' with lot number 084A067.
The recall record does not specify a remedy, so contact the manufacturer or distributor for instructions.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0282-2025 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0282-2025 from FDC Limited. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
