FDA (Drugs) recall action 72016
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
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.
Allergan is recalling Refresh P.M. eye ointment because small black particles from the tube cap may have entered the product.
Allergan is recalling Refresh Lacri-Lube eye ointment because unscrewing the cap may introduce small black particles into the product.
Allergan is recalling specific lots of FML ophthalmic ointment because small black particles from the tube cap may be present in the product.
Allergan is recalling 337 tubes of Blephamide ophthalmic ointment because small black particles from the tube cap may be present in the product.