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 a specific lot of fentanyl and bupivacaine injection due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl injection bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl citrate injection bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Phenylephrine 200 mg in 0.9% Sodium Chloride 250 mL injections due to a 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 fentanyl syringes because they may leak and lack assurance of sterility.
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 specific lots of Potassium Chloride 20 meq in Sodium Chloride 0.9% injection due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of fentanyl infusion bags because they may leak and lack assurance of sterility.
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.2% bags because they may leak and lack sterility assurance.
SCA Pharmaceuticals is recalling Phenylephrine 100 mg injection bags because they lack assurance of sterility and may leak.
SCA Pharmaceuticals is recalling specific lots of Phenylephrine 50 mg injection due to a lack of assurance of sterility and potential for product leakage.
SCA Pharmaceuticals is recalling ePHEDrine Sulfate syringes due to a lack of assurance of sterility and potential for leaking.
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 specific lots of Phenylephrine 10 mg IV bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for product leakage.
SCA Pharmaceuticals is recalling Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling fentanyl citrate syringes due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of Bupivacaine HCl 0.125% bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling Phenylephrine 20 mg IV bags due to a lack of assurance of sterility and potential for leaking.
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl injection because the product lacks assurance of sterility and has the potential to leak.