Class II · Moderate risk
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
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 II · Moderate risk
Oxygen
cGMP Deviations
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Tiglutik (riluzole)
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk
Integrity Biochem HSC 70-VA
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC70-LV
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC 70-LM
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.