FDA (Drugs) recall action 85826
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.
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
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.
Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.
Somerset Therapeutics is recalling 383,437 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2% because a slow leaching process from the product label may impact the product over its shelf life.
Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.