Class IIReported 2025-07-02

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 Number

D-0495-2025

Classification

Class II

Status

Ongoing