Class II · Moderate risk Terminated
Rocuronium Br 100 mg/10mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
neostigmine methylsulfate 5 mg/5 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Lidocaine HCl 2% 5 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Lidocaine HCl 1% 10 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Glycopyrrolate 1 mg/5mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
fentaNYL 1500 mcg/30 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Esmolol HCl 100 mg/10 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Buffered Lidocaine HCl
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Atropine Sulfate Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Ascend Laboratories
Reason Failed Impurity/Degradation Specifications