FDAFDA · Food and drugs·Recall number D-0495-2025
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Published July 2, 2025 · Recall initiated: May 28, 2025
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
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Distributor
- US Nationwide.
- Lot
- Batch VD1654, Exp Date: 06/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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