Akorn recalls Ketorolac Tromethamine Ophthalmic Solution 0.5% due to CGMP deviations. This prescription eye drop may pose risks if used improperly. Check NDC numbers and expiration dates for affected lots.
CGMP Deviations:
Akorn is recalling certain lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% eye drops due to manufacturing quality control issues. This recall affects prescription eye drops that could have safety risks if used without proper quality control.
The recall is for products that failed quality control checks during manufacturing. This means the eye drops might not meet safety standards, potentially causing eye irritation or other issues if used improperly.
Prescription eye drop users who have the specific lot numbers listed in the recall. Patients with eye conditions requiring Ketorolac may be at higher risk if they use the affected products.
Check the product label for the NDC numbers: 17478-209-10, 17478-209-11, or 17478-209-19. Also look for the expiration date and lot number listed in the recall notice.
Look for the NDC numbers 17478-209-10, 17478-209-11, or 17478-209-19 on the bottle.
The product was recalled due to CGMP deviations, which means the manufacturing process did not meet quality control standards.
The recall does not specify a remedy, so contact Akorn directly for guidance on next steps.
Yes, specific lot numbers are listed in the recall notice, including 1A09A, 1H01A, 1E32A, and others with their expiration dates.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0141-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0141-2023 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.
