Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
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
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection
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
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ketamine Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 50 mcg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Succinylcholine Cl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
PHENYLephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Famotidine Tablets
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk Ongoing
Pyrazinamide
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Ongoing
Ketotifen Fumarate 0.025 %
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
LORazepam Injection
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
HyperLyte CR Injection
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
HyperLyte CR Injection
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
Lidocaine 2% HCl Inj
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
Potassium Acetate Injection
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
Sodium Phosphates Injection 4 mEq/3 mMol/mL
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
Msa 7.84% Msg 8.56%
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
vasopressin 50 units added to 0.9% sodium chloride 50 mL*
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.