Apotex Corp. recalled 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL. It was manufactured by Apotex Inc. in Richmond Hill, Ontario, and distributed nationwide in the U.S.
The recall was initiated due to a lack of assurance of sterility. Improper bottle sealing resulted in atypical weight loss, raising potential sterility concerns.
No specific injuries or incidents have been reported related to this recall. The potential for sterility issues poses a high risk.
Stop using the product immediately. Contact Apotex Corp. or your healthcare provider for further guidance on the recall.
For more information, visit the FDA's enforcement report at the provided link or contact Apotex Corp.
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