FDAFDA · Food and drugs·Recall number D-0787-2023
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
Published June 7, 2023 · Recall initiated: April 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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