Akorn recalls all Tobramycin Ophthalmic Solution 0.3% 5mL bottles due to stability concerns after manufacturer went out of business. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Tobramycin Ophthalmic Solution 0.3% 5mL bottles (Rx only) because the manufacturer went out of business and can no longer ensure product stability. This means the medication may not be safe for use.
The manufacturer went out of business and can no longer conduct stability studies. This means the product's safety and effectiveness cannot be guaranteed over time, potentially leading to ineffective treatment or adverse reactions.
Prescription users of Tobramycin Ophthalmic Solution 0.3% 5mL bottles. Patients with eye infections requiring this medication are most at risk.
Check for Tobramycin Ophthalmic Solution 0.3% 5mL bottles labeled as Rx only. All products manufactured by Akorn, Inc. in Lake Forest, IL are affected.
Identify the product by checking the NDC number and lot number on the bottle.
The official recall notice does not provide any remedy.
The manufacturer went out of business and can no longer continue stability studies.
All Tobramycin Ophthalmic Solution 0.3% 5mL bottles (Rx only) manufactured by Akorn, Inc. in Lake Forest, IL are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0851-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0851-2023 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.
