Akorn recalls 0.2% ophthalmic solution bottles due to stability problems after the manufacturer closed. All units affected; no remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 5mL ophthalmic solution bottles because the company went out of business and can no longer ensure product stability. This means the medication may not be safe for use once the manufacturer stopped operations.
The manufacturer went out of business and stopped stability testing, meaning the product's safety and effectiveness could degrade. Without ongoing testing, the medication might not work as intended or could cause harm.
People with prescriptions for this eye drop medication are affected. Those who have the product and are using it could be at risk if the medication degrades over time.
Check for 5mL bottles labeled 'Olopatadine HCl Ophthalmic Solution, USP, 0.2%'. All units are affected regardless of lot number or date.
Identify the product by checking the label for the 5mL bottle size and 'Olopatadine HCl Ophthalmic Solution, USP, 0.2%'.
The recall notice states no remedy is provided, so there is no fix or action to take.
Look for 5mL bottles labeled 'Olopatadine HCl Ophthalmic Solution, USP, 0.2%'. All units are affected regardless of lot number or date.
The manufacturer went out of business and stopped stability testing, so the product's safety and effectiveness cannot be guaranteed.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0860-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0860-2023 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.
