Recall: D-0495-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-28Initiated

OngoingStatus

Apotex Corp.Firm

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

Lack of Assurance of Sterility

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.