Akorn recalls 4% Cromolyn Sodium Ophthalmic Solution 10mL bottles due to CGMP deviations. Affected lots expire by 2024. No remedy specified in official notice.
CGMP Deviations:
Akorn is recalling Cromolyn Sodium Ophthalmic Solution 4% 10mL bottles that were manufactured with CGMP deviations. This recall affects patients using prescription eye drops for conditions like allergic conjunctivitis. The hazard could lead to unsafe product quality but no specific injury risk is described in the recall notice.
The product was manufactured with CGMP deviations, which are deviations from current Good Manufacturing Practices. These deviations could affect the product's quality and safety, but the recall does not specify the exact nature of the hazard or potential injuries.
Patients with a prescription for Cromolyn Sodium Ophthalmic Solution 4% 10mL bottles from Akorn, Inc. in Lake Forest, IL. Those using the product during the specified production lots are most at risk.
Check the product label for the brand 'Akorn', product name 'Cromolyn Sodium Ophthalmic Solution 4%', and the lot numbers 0G75A, 0G12A, 0H50A, 0J88A, 1D98A, 1E31A, 1D97A, or 1H14A. The expiration dates for these lots range from June 30, 2023, to July 31, 2024.
Look for the lot numbers 0G75A, 0G12A, 0H50A, 0J88A, 1D98A, 1E31A, 1D97A, or 1H14A on the bottle.
The recall states there were CGMP deviations but does not specify if the product is unsafe. No remedy is provided, so the official notice does not confirm risks.
The recall does not specify a remedy, so no action is required beyond checking the product label for the affected lot numbers.
Check the product label for the lot numbers 0G75A, 0G12A, 0H50A, 0J88A, 1D98A, 1E31A, 1D97A, or 1H14A.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0137-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0137-2023 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.
