Akorn recalls Tobramycin Ophthalmic Solution 0.3% 5mL dropper bottles due to CGMP deviations. This medication is prescription-only and may pose safety risks if used improperly.
CGMP Deviations:
Akorn is recalling prescription Tobramycin Ophthalmic Solution 0.3% 5mL dropper bottles because of manufacturing deviations. This recall affects patients using the medication for eye infections and requires them to contact their doctor for alternatives.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which means the medication may not be produced safely or consistently. This could lead to ineffective treatment or potential safety issues for patients using the product.
Prescription patients using Tobramycin Ophthalmic Solution 0.3% 5mL dropper bottles manufactured by Akorn, Inc. are most at risk if they have the recalled lot numbers.
Check the product label for the NDC code 17478-290-10 and lot numbers 1C56A (exp 2/28/2023), 1J50A (exp 8/31/2023), 1K61A (exp 9/30/2023), or 1M27A (exp 11/30/2023).
Look for the NDC code 17478-290-10 and lot numbers 1C56A, 1J50A, 1K61A, or 1M27A on the bottle.
The recall is due to CGMP deviations, which means the medication may not be produced safely or consistently. Patients should not use the recalled product and contact their doctor for alternatives.
The recall does not specify a remedy, so you should check with your doctor or pharmacist for guidance on safe alternatives.
Check the product label for the NDC code 17478-290-10 and lot numbers 1C56A (exp 2/28/2023), 1J50A (exp 8/31/2023), 1K61A (exp 9/30/2023), or 1M27A (exp 11/30/2023).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0157-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0157-2023 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.
