Class II · Moderate risk
Idarubicin Hydrochloride Injection 20 mg/20 mL
Lack of Assurance of Sterility
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
Amikacin Sulfate Injection USP 1 gram/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection 100 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility
Class II · Moderate risk
DAUNOrubicin Hydrochloride Injection 20 mg/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
Compounded Lyophilized AOD-9604
Lack of Assurance of Sterility
Class II · Moderate risk
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine (Povidone-Iodine)
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Vecuronium Bromide for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Toposar (etoposide injection USP)
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.