FDA (Drugs) recall action 71415
The FDA (Drugs) publishes a recall like this one as 54 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 54 pages.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured
Lack of Assurance of Sterility: Sterility of product is not assure
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.
Lincare, Inc. is recalling compounded Vancomycin and Heparin products because the sterility of the product is not assured. The recall affects products distributed in Arkansas.
Lincare, Inc. is recalling Gentamicin Sulfate syringes compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling specific lots of compounded Hydromorphone HCl IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling Vancomycin HCl bags compounded by United Medical IV Center because the sterility of the product is not assured.