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 specific lots of Hydromorphone HCl IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.
Lincare, Inc. is recalling Vancomycin HCl in Dextrose IV bags because the sterility of the product is not assured. The affected bags were compounded in Arkansas.
Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.
Lincare, Inc. is recalling Deferoxamine Mesylate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
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 Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling Cefepime HCl IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling specific lots of Ganciclovir Sodium IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling specific Fluorouracil IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling specific compounded Morphine Sulfate bags because the sterility of the product is not assured. The affected bags were distributed in Arkansas.
Lincare, Inc. is recalling Fentanyl Citrate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 2:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling Ciprofloxacin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling 3 bags of Cefepime 1gm/NS 50mL AccuFlo compounded in Little Rock, Arkansas, 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.