FDA (Drugs) recall action 96032
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
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.
AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.
AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was distributed nationwide.