Class II · Moderate risk
Rocuronium Br 100 mg/10mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
PHENYLephrine HCl 800 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
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
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