FDA (Drugs) recall action 96954
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.