FDA (Drugs) recall action 68497
The FDA (Drugs) publishes a recall like this one as 30 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 30 pages.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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.
Trinity Care Solutions is recalling 14 units of Tobramycin 300 mg/7.5 mL syringes in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling 8 units of compounded Cubicin 600 mg/100 mL due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling 21 units of Impipenem/Cilastin (Primaxin) 500 mg/100 mL due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling Desferal sterile compounds in Florida due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling compounded Cubicin 543 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling 21 units of Vancomycin 1 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling ANA Kits due to quality control concerns identified during an FDA inspection regarding the assurance of sterility.
Trinity Care Solutions is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling compounded Cubicin 700 mg/100 mL due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 60 units of Unasyn (ampicillin/sulbactam) in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling compounded Cubicin 444 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.
Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 7 units of compounded Levofloxacin 750 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/250 mL due to lack of assurance of sterility identified during an FDA inspection.
Trinity Care Solutions is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W due to quality control concerns identified during an FDA inspection.
Trinity Care Solutions is recalling 7 units of compounded Cubicin in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling Cefepime 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.
Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling 22 units of Vancomycin 750 mg/100 mL in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling 7 units of Pfizerpen (penicillin G) compounded in Florida due to quality control concerns regarding sterility assurance.
Trinity Care Solutions is recalling Ambisome 285 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.
Trinity Care Solutions is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W in Florida due to quality control concerns identified during an FDA inspection.