FDA (Drugs) recall action 68497
The FDA (Drugs) publishes a recall like this one as 30 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 30 pages.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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.
Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/100 mL 0.9%NS in Florida due to lack of assurance of sterility identified during an FDA inspection.
Trinity Care Solutions is recalling 21 units of Vancomycin 1 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 11 units of Cefepime 2 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 12 units of compounded Invanz in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.