FDA (Drugs) recall action 77533
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 Sterility Assurance
The agency’s own wording, quoted from the enforcement report.
Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.
Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.
Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.
Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.