FDA (Drugs) recall action 85829
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
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.
Rising Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to a carton label mix-up where 0.25% bottles were shipped in 0.5% cartons.
Rising Pharmaceuticals is recalling 15,072 bottles of Timolol Maleate 0.25% ophthalmic solution because some outer cartons were mislabeled as 0.5% strength.