Akorn recalls all batches of AK-POLY-BAC ophthalmic ointment due to CGMP deviations after the company went out of business and could no longer conduct stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all batches of AK-P:POLY-BAC ophthalmic ointment because the company went out of business and stopped stability testing. This means the product may not be safe for use as it could degrade over time.
The recall is due to the manufacturer going out of business and being unable to continue stability testing. This means the product's safety and effectiveness over time could not be confirmed, though it does not pose an immediate risk of injury.
Prescription ophthalmic ointment users who have the AK-POLY-BAC product. Those most at risk are individuals with eye conditions requiring regular use of this medication.
Check for the product name AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) ophthalmic ointment, 3.5g, sterile, prescription-only. All lots and all NDC numbers are affected.
Verify the product name, strength, and prescription status to confirm it matches the recalled items.
The recall is due to the manufacturer going out of business and stopping stability testing, so the product's safety cannot be confirmed. It is not recommended for use.
The recalled product is AK-POLY-BAC ophthalmic ointment, 3.5g, sterile, prescription-only. All lots and all NDC numbers are affected.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to use the product or seek alternatives.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0788-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0788-2023 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.
