Class II · Moderate risk
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Rocuronium Bromide 50 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Lidocaine HCl 1%
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium 5
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Glycopyrrolate 1 mg/5 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 1
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Phenylephrine HCl 1 mg/10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride 1 g/50 mL* Added to 5% Dextrose
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class III · Low risk
Sodium Ferric Gluconate Complex in Sucrose Injection
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class II · Moderate risk
Desoximetasone Ointment USP
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Class I · High risk
Ultimate Body Tox PRO capsules
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk
Lactulose Solution
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.