Class II · Moderate risk Terminated
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Rocuronium Bromide 50 mg/5 mL Injection Solution
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Lidocaine HCl 1%
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Heparin Sodium 5
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Heparin Sodium
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Glycopyrrolate 1 mg/5 mL
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Fentanyl Citrate 2
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Fentanyl Citrate 1
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Calcium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Calcium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Phenylephrine HCl 1 mg/10 mL
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Calcium Chloride 1 g/50 mL* Added to 5% Dextrose
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class II · Moderate risk Terminated
L-Cysteine Hydrochloride Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class II · Moderate risk Terminated
L-Cysteine Hydrochloride Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.