FDA (Drugs) recall action 90080
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
CGMP Deviations
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.
SCA Pharmaceuticals voluntarily recalled 424 bags of fentanyl and bupivacaine injectable solution due to manufacturing control deviations. The product was distributed nationwide in the United States.
SCA Pharmaceuticals has recalled Vancomycin HCl 1.5g injection bags due to manufacturing process deviations. The product was distributed nationwide.
SCA Pharmaceuticals recalled 120 bags of Norepinephrine 8mg injection nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall was initiated April 25, 2022.