Akorn recalls AK-POLY-BAC Bacitracin and Polymixin B Sulfate Ophthalmic Ointment due to CGMP deviations. This prescription ointment may not meet quality standards.
CGMP Deviations:
Akorn is recalling a specific prescription ophthalmic ointment product due to manufacturing quality issues. This recall affects patients who have been prescribed this medication and may not meet the required quality standards for safe use.
The recall is due to CGMP (Current Good Manufacturing Practices) deviations, which means the product may not meet the required quality standards. This could potentially affect the safety and effectiveness of the medication.
Prescription patients who have been prescribed this ophthalmic ointment. Those with the specific product details listed in the recall are most at risk.
Check for the AK-POLY-BAC brand name, 3.5 g (1/8 oz.) tube, and the expiration date of 06/30/2023. This product is prescription-only and manufactured by Akorn, Inc.
Look for the AK-POLY-BAC brand, 3.5 g (1/8 oz.) tube, and expiration date of 06/30/2023 on the product label.
The recall states there were CGMP deviations, but the official notice does not specify if the product is safe to use.
Check for the AK-POLY-BAC brand, 3.5 g (1/8 oz.) tube, and expiration date of 06/30/2023 on the product label.
The recall does not specify a remedy, so the official notice does not state what action to take.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0132-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0132-2023 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.
