Ketorolac Ophthalmic Solution Recalled for Sterility Concerns Due to Improper Bottle Sealing
Apotex Corp. is recalling approximately 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution nationwide due to lack of sterility assurance from improper bottle sealing. The defect may allow contamination of the eye medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall qualifies as High severity per the 'risk-of-harm products where injury has not yet been reported' rubric criterion. The lack of sterility assurance in a prescription ophthalmic medication represents a genuine risk of contamination, though no injuries have yet been reported.
Plain-English summary
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL bottles nationwide in the United States. Approximately 493,468 bottles have been distributed. Ketorolac Tromethamine is a prescription-only eye medication.
The recall was issued due to lack of assurance of sterility caused by improper bottle sealing. This manufacturing defect may result in compromised sterility, potentially exposing patients to contamination of the solution.
The recalled batches are identified as VA0444, VA4608, and TZ7016, with expiration dates of December 2025 or January 2026. The product NDC is 60505-1003-1. Patients who have used this product from the affected batches should consult their healthcare provider for guidance.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic
- Hazard
- lack-of-sterility
- improper-sealing
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # VA0444
- exp. date 01/2026 Batch # VA4608
- exp. date 01/2026 Batch # TZ7016
UPCs (1)
- 360505100316
Distribution
Distributed nationwide across the United States.
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