Akorn recalls Fluticasone Propionate Nasal Spray 50mcg 16g bottles due to stability concerns after manufacturer closure. All units affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling Fluticasone Propionate Nasal Spray 50mcg 16g bottles because the manufacturer went out of business and can no longer ensure product stability. This means the spray may not be safe for use as it could degrade over time.
The manufacturer went out of business and could no longer conduct stability studies. This means the product's safety and effectiveness over time cannot be guaranteed, potentially leading to reduced efficacy or unintended effects.
People who own or use the Akorn Fluticas:one Propionate Nasal Spray 50mcg 16g bottles are affected. Those with ongoing medical needs are most at risk due to potential product degradation.
Check for Akorn Fluticasone Propionate Nasal Spray 50mcg 16g bottles with all NDCs and lots. The product was manufactured by HI-TECH PHARMACAL CO., INC., Amiy.
Identify the product by checking the label for Akorn Fluticasone Propionate Nasal Spray 50mcg 16g bottles with all NDCs and lots.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety and effectiveness cannot be guaranteed.
The official recall does not provide a remedy; the product is being recalled due to the manufacturer's closure.
Check for Akorn Fluticasone Propionate Nasal Spray 50mcg 16g bottles with all NDCs and lots manufactured by HI-TECH PHARMACAL CO., INC., Amiy.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0804-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0804-2023 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.
