FDA recall D-0494-2025

Apotex Corp. · Class II · drug

Product

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2

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-0494-2025