FDA (Drugs) recall action 77595
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
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.
Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate IV bags nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection due to a lack of assurance of sterility. The recall affects 2,350 units distributed nationwide.
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.