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 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL due to lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags because they may leak and lack assurance of sterility.
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.
SCA Pharmaceuticals is recalling specific lots of Hydromorphone injection syringes because they may leak and lack assurance of sterility.
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.1% bags due to a lack of assurance of sterility and potential for leaking.