FDA (Drugs) recall action 82969
The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.
Lack of Processing Controls.
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.
Synthetopes Inc is recalling Sn-d, l-Exametazime vials nationwide due to a lack of processing controls. The FDA classifies this as a Class II recall.
Synthetopes Inc is recalling Sn-Tetrofosmin Kits nationwide due to a lack of processing controls. All lots remaining within their expiry date are affected.
Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.
Synthetopes Inc is recalling Sn-Mertiatide Kits nationwide due to a lack of processing controls. The recall covers all lots remaining within their expiry date.
Synthetopes Inc. is recalling Sulfur Colloid Reaction Vials nationwide due to a lack of processing controls.
Synthetopes Inc. is recalling Sn-Pyrophosphate Kits because of a lack of processing controls. The recall covers all lots remaining within their expiry dates.
Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.
Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.