Akorn recalls Timolol Maleate Ophthalmic Solution 0.5% due to CGMP deviations. Products with specific NDCs and expiration dates are affected. Consumers should check their bottles for the listed lot numbers and expiration dates.
CGMP Deviations:
Akorn is recalling Timolol Maleate Ophthalmic Solution 0.5% products due to manufacturing quality control issues. This recall affects specific bottle sizes and lot numbers that may have been produced under improper conditions. If you have these products, you should check the lot numbers and expiration dates to see if they are affected.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which means the medication was produced under conditions that do not meet the strict quality standards required for safe and effective pharmaceuticals. This could potentially affect the medication's safety and efficacy, though the specific risks are not detailed in the recall notice.
People who have the recalled Timolol Maleate Ophthalmic Solution 0.5% products, specifically those with the listed NDC numbers and expiration dates. Prescribers and patients using the medication are most at risk if they have the affected lots.
Check the product label for the NDC numbers: 17478-288-10 (5 mL), 17478-288-11 (10 mL), or 17478-288-12 (15 mL). Also look for the lot numbers listed in the expiration dates provided in the recall notice.
Look for the NDC numbers (17478-288-10, 17478-288-11, or 17478-288-12) and the lot numbers listed in the recall notice.
The recall is due to CGMP deviations, which means the medication was produced under conditions that do not meet the strict quality standards required for safe and effective pharmaceuticals.
Check the product label for the NDC numbers and lot numbers listed in the recall notice to see if your product is affected. If it is, you should contact Akorn for further instructions.
Yes, the recall includes specific expiration dates for each lot number. Check the product label for the lot numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0156-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0156-2023 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.
