FDA (Drugs) recall action 78320
The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.
Lack Of Assurance Of Sterility.
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 recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling 487 syringes of Rocuronium Bromide 10 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
SCA Pharmaceuticals is recalling 76 bags of Calcium Gluconate 2 g in 0.9% Sodium Chloride due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine CADD cassettes due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling 60 bags of Hydromorphone and Bupivacaine injection due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling 1,221 syringes of Phenylephrine HCl 100 mcg/mL due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection due to a lack of assurance of sterility.
SCA Pharmaceuticals is recalling 116 bags of fentanyl and bupivacaine injection due to a lack of assurance of sterility.