Akorn recalls Ciprofloxacin Ophthalmic Solution 2.5mL bottles (Rx only) manufactured with CGMP deviations. No remedy specified in official notice.
CGMP Deviations:
Akorn has recalled Ciprofloxacin Ophthalmic Solution 2.5mL bottles (Rx only) due to manufacturing deviations. This affects patients using the medication as prescribed by a doctor.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations during production. This means the medication may not meet quality standards, but the specific risk to patients is not detailed in the notice.
Patients prescribed this eye drop medication by a doctor. Those using the product without a prescription are not affected.
Check for the product name 'Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle' with NDC 17478-714-25 and lot number 1E22A (expiring 10/31/2022).
Verify the product name, NDC number 17478-714-25, and lot number 1E22A on the bottle.
The recall notice states CGMP deviations but does not specify if the medication is unsafe for use.
The official notice does not provide a remedy, so no action is required beyond checking the product details.
No, this medication is prescription-only (Rx Only) as stated in the product description.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0136-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0136-2023 from Akorn. 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.
