FDA (Drugs) recall action 69494
The FDA (Drugs) publishes a recall like this one as 11 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 11 pages.
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
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.
Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.
Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures that may compromise sterility.
Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.
Hospira is recalling 305,664 bags of Normosol-R Multiple Electrolytes Injection due to potential punctures that may compromise sterility and cause leaks.
Hospira is recalling 301,560 bags of 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.