FDA (Drugs) recall action 86990
The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 751 syringes of Morphine Sulfate 3 mg/3 mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes due to a lack of assurance of sterility and potential defective caps.