FDA (Drugs) recall action 90982
The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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.
Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.
The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.
Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee sterility.
Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.