Recall D-0495-2025

US Class II Ongoing · initiated 2025-05-28

Recalling firm

Apotex Corp., FL

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

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