FDA (Drugs) recall action 73032
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.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
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.
Bausch & Lomb is recalling Tropicamide Ophthalmic Solution because the package insert is missing updates compared to the reference drug insert.
Bausch & Lomb is recalling Cyclopentolate Hydrochloride Ophthalmic Solution 1% because the package insert is missing updates compared to the reference drug insert.
Bausch & Lomb is recalling Tropicamide Ophthalmic Solution 0.5% because the package insert is missing updates compared to the reference drug insert.