FDA recall D-0495-2025

Apotex Corp. · Class II · drug

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

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-05-28
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2025