FDA (Drugs) recall action 74539
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.
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
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.
Vital Care Compounder is recalling 9 vials of Brilliant Blue G injection due to a defect in the aluminum crimps that may compromise sterility.
Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml because aluminum crimps may not fully seal the rubber stoppers, compromising sterility.
Vital Care Compounder is recalling 54 vials of Trypan Blue 0.3% because aluminum crimps may not fully seal the rubber stopper, compromising sterility.