Product: 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
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20250528
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated