Class II · Moderate risk
Glutathione 200mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Methylcobalamin 1mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Acetylcysteine for Injection 6 g/30 mL
CGMP Deviations
Class II · Moderate risk
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Class II · Moderate risk
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class II · Moderate risk
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 16 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 8 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 4 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
PHENYLephrine 10 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
PHENYLephrine 20 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
NORepiNEPHrine4mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
NORepiNEPHrine4mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
NORepiNEPHrine Bitartrate
Lack of Assurance of Sterility: Potential leakage of bags.