← FDA ENFORCEMENT
D-0494-2025Class II

Apotex Corp.

Recalling firm
Apotex Corp.
Product type
Drug
Status
Ongoing
Report date
2025-07-02
Distribution
US Nationwide.
Firm state
FL
Product quantity
87,840 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Batch TZ1236, Exp Date: 11/30/2025

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.