FDA (Drugs) recall action 65288
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
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.
Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare is recalling specific lots of Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare is recalling specific lots of Lidocaine Hydrochloride and 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare Corp. is recalling specific lots of Metronidazole Injection USP due to a manufacturing defect that may compromise sterility.