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.
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Sodium Ferric Gluconate Complex in Sucrose Injection
Reason Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Class I · High risk Terminated
Ultimate Body Tox PRO capsules
Reason 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 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.