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 390 syringes of neostigmine methylsulfate due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 5,067 syringes of Succinylcholine Chloride 100 mg/5mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 23,029 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling Atropine Sulfate Injection syringes due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling Lidocaine HCl 1% syringes due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection syringes due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 428 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling 3,239 syringes of Succinylcholine Chloride 200 mg/10 mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% because defective caps may compromise sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL due to a lack of assurance of sterility and potential defective caps.
SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.