FDA (Drugs) recall action 77770
The FDA (Drugs) publishes a recall like this one as 30 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 30 pages.
Lack of Assurance of Sterility; product has the potential to leak.
The agency’s own wording, quoted from the enforcement report.
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL bags because they may leak and lack assurance of sterility.
SCA Pharmaceuticals is recalling NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Phenylephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Epinephrine HCl 4 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for leaking.