FDA (Drugs) recall action 84082
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.
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.
Sandoz Inc is recalling 76,644 bottles of Gatifloxacin Ophthalmic Solution 0.5% because the package insert is incorrect or missing.
Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension due to incorrect or missing package inserts.
Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03% because the package insert is incorrect or missing. The recall covers 346,929 bottles distributed nationwide.