FDA (Drugs) recall action 80118
The FDA (Drugs) publishes a recall like this one as 23 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 23 pages.
Lack of sterility assurance.
The agency’s own wording, quoted from the enforcement report.
Guardian Pharmacy Services is recalling 100 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling Cefazolin 2 Gm/20 mL syringes in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 100 syringes of compounded Glycopyrrolate 0.2 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL TPN in Texas due to lack of sterility assurance.
Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 442 syringes of Hyaluronidase 150 units/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling specific lots of compounded Glutathione 200 mg/mL vials in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL 750 mL ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.
Guardian Pharmacy Services is recalling 250 syringes of Lidocaine 3% in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 2,000 vials of compounded Methylcobalamin 1000 mcg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 300 syringes of Fentanyl Citrate 50 mcg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling B-Complex products in 100 mL bags and vials due to a lack of sterility assurance. The affected units were distributed in Texas.
Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes due to a lack of sterility assurance. The product was distributed in Texas.
Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.
Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 4,900 vials of Ascorbic Acid 500 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 95 vials of Methylene Blue 10 mg/mL in 1 mL syringes due to a lack of sterility assurance. The product was distributed in Texas.
Guardian Pharmacy Services is recalling 250 vials of MIC B Combo Lipotropic in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL in ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.
Guardian Pharmacy Services is recalling Hyaluronidase 150 units/mL vials in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 1,000 vials of Magnesium Sulfate 200 mg/mL in Texas due to a lack of sterility assurance.