Akorn recalls all 50 mg/mL 1mL intravenous ephedrine sulfate ampules due to inability to conduct stability studies after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all intravenous ephedrine sulfate injection ampules because the manufacturer went out of business and can no longer ensure the product's stability. This means the medication may not be safe for use after the recall date.
The manufacturer went out of business and could no longer perform stability testing on the product. This means the medication's safety and effectiveness over time cannot be guaranteed, potentially leading to adverse effects if used.
Healthcare professionals who use this medication for intravenous administration are affected. Patients receiving this treatment under a prescription are at risk if they use the recalled product.
Check for Akorn-branded ephedrine sulfate injection ampules labeled 50 mg/mL, 1mL single dose, for intravenous use. All lots and all National Drug Codes (NDCs) are affected.
Identify the product by checking the label for 50 mg/mL, 1mL single dose, intravenous use, and Akorn as the manufacturer.
The manufacturer went out of business and could no longer continue stability studies, making the product's safety uncertain.
The recall record does not specify any remedy steps.
Look for Akorn-branded ephedrine sulfate injection ampules labeled 50 mg/mL, 1mL single dose, for intravenous use. All lots and all National Drug Codes (NDCs) 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-0802-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0802-2023 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.
