Azelastine HCl Ophthalmic Solution recalled over sterility concerns
- Recall date
- May 28, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,…
- Recall number
- D-0495-2025
- FDA classification
- Class II
- Brand / firm
- Apotex Corp.
- Sold / distributed
- US Nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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