Class II · Moderate risk Terminated
Acetylcysteine for Injection 6 g/30 mL
Reason CGMP Deviations
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Reason Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Class II · Moderate risk Terminated
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Reason Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class II · Moderate risk Terminated
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag
Reason 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 Terminated
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag
Reason 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 Terminated
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag
Reason 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 Terminated
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag
Reason 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 Terminated
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag
Reason 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 Terminated
Norepinephrine Bitartrate 16 mg
Reason 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 Terminated
Norepinephrine Bitartrate 8 mg
Reason 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 Terminated
Norepinephrine Bitartrate 4 mg
Reason 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 Terminated
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag
Reason 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 Terminated
Fentanyl
Reason 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 Terminated
Fentanyl
Reason 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 Terminated
Morphine Sulfate 1 mg/mL
Reason 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 Terminated
PHENYLephrine 10 mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
PHENYLephrine 20 mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine4mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine4mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine Bitartrate
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine 16
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Midazolam 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Midazolam 0.5mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.