FDA-Drug2025-07-02Class II
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
Apotex Corp.
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide.
Affected count
105,456 Bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, Weston, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2025Don't want to check this manually?
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