FDA (Drugs) recall action 80303
The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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 is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.