Class II · Moderate risk
Baxter LL bag 2% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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Class II · Moderate risk
Baxter LL bag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1% Amino Acids w/KCL
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 45 - 51 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 90+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 80+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 70+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Proplete 60 - 69 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 52 - 59 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 40 - 44 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Idpn
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Fresenius bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Baxter LL bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter Ultrabag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 34 - 39 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class I · High risk
Trace Mineral-5 MDV
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Class II · Moderate risk
Tri-Mix Injections in 5 mL and 10 mL vials
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
MIC (Methionine, Inositol, and Choline)
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Praziquantel 56.8 mg
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Carnosine 5% Opth drop
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Morphine Sulfate 25 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
MIC (Methionine, Inositol, and Choline)
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Phosphatidyl Choline 10%
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
B-Complex 100 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes