FDA recall D-0677-2025

Apotex Corp. · Class II · drug

Product

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

Reason for recall

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2025-09-05
Report date
2025-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0677-2025