Akorn recalls all Diuril (chlorothiazide sodium) injections due to stability problems after the manufacturer ceased operations. No remedy provided; affected patients should contact their doctor.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Diuril (chlorothiazide sodium) injections because the manufacturer went out of business and could no longer conduct stability testing. This means the medication may not be safe for use as the quality cannot be guaranteed.
The manufacturer went out of business and stopped conducting stability studies, which are necessary to ensure the medication remains safe and effective over time. Without this testing, there's a risk the medication could degrade or become unsafe.
Patients prescribed Diuril injections by a doctor are affected. Those who have the medication and are unsure if it's safe should consult their healthcare provider.
This recall applies to all Diuril injections (500mg/vial, single-dose vials) with any lot number. The product is distributed by Akorn Operating Company, LLC. in Gurnee, Illinois.
Since no remedy is provided, patients should talk to their healthcare provider about the recalled medication.
The recall states the manufacturer could no longer conduct stability testing, so the safety of the medication cannot be guaranteed. Patients should not use it without consulting their doctor.
The recall does not provide a specific remedy, so patients should contact their doctor for guidance.
The manufacturer went out of business and could no longer continue stability studies, which are needed to ensure the medication remains safe and effective.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0800-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0800-2023 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.
