FDA (Drugs) recall action 75745
The FDA (Drugs) publishes a recall like this one as 21 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 21 pages.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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.
Cantrell Drug Company is recalling Fentanyl Citrate bags due to a lack of assurance of sterility. The recall affects 2,545 bags distributed nationwide.
Cantrell Drug Company is recalling 2,509 single-dose Hydromorphone HCl syringes nationwide due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 5,067 syringes of Rocuronium Bromide 50 mg/5 mL injection solution nationwide due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Cantrell Drug Company is recalling specific lots of Glycopyrrolate injection because the firm cannot assure the sterility of the product.
Cantrell Drug Company is recalling 1,494 syringes of Heparin Sodium due to a lack of assurance of sterility. The products were distributed nationwide.
Cantrell Drug Company is recalling 150 bags of Heparin Sodium 5,000 USP Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Cantrell Drug Company is recalling specific lots of Fentanyl Citrate and Bupivacaine HCl bags due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 37 syringes of Midazolam HCl 50 mg/50 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Cantrell Drug Company is recalling 645 vials of Calcium Chloride Injection Solution because the firm cannot assure the sterility of the product.
Cantrell Drug Company is recalling 1,748 bags of Morphine Sulfate 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Cantrell Drug Company is recalling 935 vials of Hydromorphone HCl 50 mg/50 mL single-dose syringes due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 80 bags of Calcium Chloride 1 g/50 mL due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 30,796 syringes of Phenylephrine HCl 1 mg/10 mL due to a lack of assurance of sterility. The recall covers products distributed nationwide.
Cantrell Drug Company is recalling specific lots of Neostigmine Methylsulfate injection syringes because the firm cannot ensure the products are sterile.
Cantrell Drug Company is recalling 2,681 bags of Oxytocin 30 USP Units due to a lack of assurance of sterility. The affected product is distributed nationwide.
Cantrell Drug Company is recalling 162 syringes of Lidocaine HCl 1% because the firm cannot assure the sterility of the product.
Cantrell Drug Company is recalling 93 vials of Hydromorphone HCl injection solution nationwide due to a lack of assurance of sterility.
Cantrell Drug Company is recalling 73 bags of Calcium Chloride in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride 200 mg/10 mL injection syringes because the firm cannot ensure the products are sterile.
Cantrell Drug Company is recalling 87 bags of Ropivacaine HCl 0.25% due to a lack of assurance of sterility. The product is intended for epidural use only.