FDA (Drugs) recall action 81002
The FDA (Drugs) publishes a recall like this one as 79 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 79 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.
Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product is distributed nationwide.
Pharm D Solutions is recalling 195 vials of Trimix injection nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Trimix 30-1-30 aqueous solution because the company cannot assure the product's sterility.
Pharm D Solutions is recalling specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.