FDA (Drugs) recall action 76733
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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.
Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection due to a potential leak that may compromise sterility.
Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.
Claris Lifesciences Inc. is recalling 72,072 units of Metronidazole Injection, USP, 500 mg/100 mL, due to a potential leak that may compromise sterility.
Claris Lifesciences Inc. is recalling Levofloxacin Injection due to a potential leak that may compromise sterility. The recall covers 24,456 units distributed nationwide.