Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
FDA Drug Recalls
775 recalls, newest first
Class II · Moderate risk
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 100 mcg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class II · Moderate risk
Oxygen
cGMP Deviations
Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing