FDA (Drugs) recall action 82398
The FDA (Drugs) publishes a recall like this one as 19 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 19 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.
Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Advanced Pharma Inc. is recalling 1,850 syringes of Phenylephrine HCl Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution because the company cannot assure the product's sterility.
Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 180 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.
Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution due to a lack of assurance of sterility. The affected products were distributed nationwide.
Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.
Advanced Pharma Inc. is recalling 1,980 syringes of 2% Lidocaine HCl Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.
Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 975 units of Phenylephrine HCl injectable solution due to a lack of assurance of sterility. The product was distributed nationwide.