Akorn recalls sterile lubricant eye drops with polyvinyl alcohol 1.4% for potential manufacturing issues. Products with specific lot numbers and expiration dates are affected.
CGMP Deviations:
Akorn is recalling sterile lubricant eye drops that may have manufacturing deviations. This could pose a risk to eye health if the product is used improperly.
The product was manufactured under conditions that did not meet current Good Manufacturing Practices (CGMP). This could lead to contamination or improper formulation, potentially causing eye irritation or infection.
People who own or use the recalled lubricant eye drops with the listed lot numbers and expiration dates are affected. Those with sensitive eyes or using the product frequently may be at higher risk.
Check the product label for the lot numbers: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, 0M02A, 0M01A, 1C81A, 1D02A, 1D03A, 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, 1F46A, 1G49A, 1G50A, 1G67A, 1H04A, 1H74A, 1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, 1J44A, 1J20A. The expiration dates range from October 31, 2022, to August 31, 2023.
Look for the lot numbers listed in the recall notice to determine if your product is affected.
The product was manufactured under conditions that did not meet current Good Manufacturing Practices (CGMP).
The recall notice does not specify a remedy, so contact Akorn directly for guidance.
Yes, the products have expiration dates ranging from October 31, 2022, to August 31, 2023.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0134-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0134-2023 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.
