Class II · Moderate risk Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Is Vancomycin recalled?
147 FDA recalls mention Vancomycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vancomycin.
Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy…
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML…
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class I · High risk Terminated
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only…
Reason Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class II · Moderate risk Ongoing
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Class II · Moderate risk Terminated
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge…
Reason CGMP Deviations
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