Akorn recalls Tobramycin Ophthalmic Solution 0.3% 5mL bottles due to CGMP deviations. This prescription eye drop may have manufacturing issues affecting safety.
CGMP Deviations:
Akorn is recalling prescription Tobramycin Ophthalmic Solution 0.3% 5mL bottles because of manufacturing quality control issues. This could affect the safety and effectiveness of the medication.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which are regulatory standards for drug safety and quality. These deviations could mean the medication isn't as safe or effective as it should be.
Prescription eye drop users who have the specific lot numbers and expiration dates listed in the recall. Patients with eye infections requiring this medication are most at risk.
Check the product label for the lot numbers: 1D94A (exp 3/31/2023), 1E35A (exp 4/30/2023), or 2A06A (exp 12/31/2023). The product is a prescription eye drop sold in 5mL bottles.
Look for the lot numbers 1D94A, 1E35A, or 2A06A on the bottle.
The recall states there were CGMP deviations, but the official notice doesn't specify if the product is unsafe to use.
Check the product label for lot numbers 1D94A (exp 3/31/2023), 1E35A (exp 4/30/2023), or 2A06A (exp 12/31/2023).
The recall does not specify a remedy, so the official notice doesn't say what to do next.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0158-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0158-2023 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.
