Akorn recalls all Azelast: Hydrochloride Nasal Spray due to stability concerns after manufacturer closure. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Azelastine Hydrochloride Nasal Spray products because the manufacturer went out of business and could no longer conduct stability testing. This means the product's safety and effectiveness cannot be guaranteed.
The manufacturer went out of business and stopped stability testing. Without this testing, the product's safety and effectiveness cannot be confirmed. This could lead to potential issues with the medication over time.
All owners of this prescription nasal spray are affected. People who have this medication and need it for their condition are most at risk.
This product is a prescription nasal spray labeled 'Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray'. All units produced by Hi-Tech Pharmacal Co., INC. in Amityville, NY are affected.
Look for the product name and NDC codes on the label to confirm if it's affected.
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 notice does not provide any remedy or action steps.
This product is a prescription nasal spray labeled 'Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray' with NDC codes from Hi-Tech Pharmacal Co., INC. in Amityville, NY.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0787-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0787-2023 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.
