Akorn recalls 4% Cromolyn Sodium Ophthalmic Solution 10mL bottles due to stability concerns after manufacturer went out of business. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 4% Cromol: a prescription eye drop that may have stability issues because the manufacturer went out of business and can't do further testing. This means the product might not be safe for use.
The manufacturer went out of business and can no longer perform stability studies. This means the product's safety and effectiveness cannot be confirmed, potentially leading to ineffective treatment or adverse reactions.
Prescription eye drop users who have the 4% Cromolyn Sodium Ophthalmic Solution 10mL bottles from Akorn. People with eye conditions requiring this medication are most at risk.
Check for 4% Cromolyn Sodium Ophthalmic Solution, 10mL bottles labeled as Rx Only, manufactured by Akorn Inc. in Lake Forest, IL. All National Drug Codes (NDCs) and all production lots are affected.
Identify the product by checking the label for 4% Cromolyn Sodium Ophthalmic Solution, 10mL, Rx Only, manufactured by Akorn Inc. in Lake Forest, IL.
The recall states the manufacturer went out of business and can no longer do stability testing, so safety cannot be confirmed.
The recall record does not specify a return or disposal remedy.
The recall record does not provide specific action steps beyond checking if you have the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0797-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0797-2023 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.
