Class II · Moderate risk
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
FDA Drug Recalls
832 recalls, newest first
Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class III · Low risk
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Lidocaine HCl 2% 5 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Lidocaine HCl 1% 10 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
labetalol HCl 20 mg/4 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Glycopyrrolate 1 mg/5mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
fentaNYL 1500 mcg/30 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Esmolol HCl 100 mg/10 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Buffered Lidocaine HCl
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Atropine Sulfate Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications