FDC Limited recalls 10mL and 2.5mL Ciprofloxacin ophthalmic solution bottles due to cap stuck in nozzle. This may prevent proper use. Rx only products distributed by Leading Pharma LLC.
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 two sizes of Ciprofloxacin eye drops because the bottle cap can get stuck in the nozzle, making it hard to use the medication. This affects people who need the prescription eye drops for infections.
The cap spike can get lodged in the bottle's nozzle, making it difficult to remove the solution. This could lead to improper use of the medication if the user cannot properly dispense the drops.
People with prescription eye drops from this manufacturer who use the product. Those with the specific bottle sizes and lot numbers are most at risk.
Check for bottles labeled 'Ciprofloxacin ophthalmic solution USP 0.3%'. The 10mL bottles have NDC 69315-308-10 and the 2.5mL bottles have NDC 69315-308-02. These are prescription-only products.
Look for the NDC codes 69315-308-10 (10mL) or 69315-308-02 (2.5mL) on the bottle label.
The product is safe to use if the cap can be removed without difficulty. If the cap is stuck, it should not be used.
Check for the NDC codes 69315-308-10 (10mL) or 69315-308-02 (2.5mL) on the bottle label.
If the cap is stuck in the nozzle, do not use the product. Contact your doctor for alternative treatment.
We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0623-2024 — FDC Limited FDC Limited Hello, I own a FDC Limited that is covered by recall D-0623-2024 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.
