Akorn recalls sterile eye ointment due to non-sterility issues found during stability testing. Products may contain harmful bacteria from Bacillus cereus group. Affected lots expire June 2022 through September 2022.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Akorn is recalling sterile eye ointment products that failed sterility testing. This could mean the ointment contains harmful bacteria that might cause infection if used.
The ointment failed sterility testing during stability tests, showing contamination with bacteria from the Bacillus cereus group. This could lead to eye infections, especially in people with weakened immune systems or existing eye conditions.
People who own or use the recalled eye ointment products are affected. Those with compromised immune systems or frequent eye infections may be at higher risk.
Check for the product name 'Artificial Tears Ointment' or 'Lubricant Eye Ointment' with a net weight of 3.5g per tube. Look for lot numbers 9G01A (expiring June 2022), 9H32A (expiring July 2022), or 9K82A/B (expiring September 2022).
Look for the lot numbers 9G01A, 9H32A, or 9K82A/B on the tube packaging.
The recall indicates the product failed sterility testing and may contain harmful bacteria. Do not use the recalled products.
The recall does not specify a remedy, so contact Akorn directly for guidance.
Check for lot numbers 9G01A (expiring June 2022), 9H32A (expiring July 2022), or 9K82A/B (expiring September 2022) on the tube packaging.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0786-2021 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0786-2021 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.
