Akorn recalls 0.5% Erythromycin Ophthalmic Ointment due to CGMP deviations. This prescription eye ointment may not meet quality standards. Consumers should contact Akorn for details.
CGMP Deviations:
Akorn is recalling prescription-strength erythromycin eye ointment because of manufacturing quality issues. This recall affects specific batches produced between January 2023 and March 2024. The ointment is intended for eye use only and requires a prescription.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which means the product may not meet quality standards. This could affect the safety and effectiveness of the ointment for eye use.
Prescription holders of the specific batch numbers listed in the recall notice. People with eye conditions requiring this medication are most at risk.
Check the product label for the NDC code 17478-070-31 and batch numbers listed in the recall notice. The ointment comes in 50 unit-dose tubes per carton and requires a prescription.
Reach out to Akorn, Inc. for specific instructions on how to return or dispose of the product.
The recall indicates potential quality issues, but the official notice does not specify if the product is unsafe. Consumers should contact Akorn for details.
The affected batch numbers are listed in the recall notice: 1B14B, 1C49A, 1C49B, 1C70A, 1E09A, 1E34A, 1E34B, 1E09B, 1F37C, 1F37A, 1F37B, 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, 1H77B, 1H80A, 1H80B, 1H77A, 1J24A, 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, 1L90B, 1L90A, 1L92B, 1L92A, 1M28A, 1M35A, 1M28B, 2D20B.
Check the product label for the NDC code 17478-070-31 and the specific batch numbers 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-0139-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0139-2023 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.
