FDA (Drugs) recall action 67135
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.
Lack of Assurance of Sterility
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
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.
Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.
Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.