FDA (Drugs) recall action 77314
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: Product bags leaking at seam.
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 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.
SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, compromising sterility.
SCA Pharmaceuticals is recalling 80 bags of morphine sulfate injectable solution because the bags are leaking at the seam, compromising sterility.
SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises sterility.
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise sterility.
SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.
SCA Pharmaceuticals is recalling 240 bags of cefazolin sodium injectable due to seam leaks that compromise sterility.
SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.
SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.